Sherpa NX Balanced™
Catheter SB7EBU405 SB 7F 100CM 5PK EB40
14manufacturers in China registered for this device type
1,523catalogue numbers in this listing
15510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K232190 |
| Record published | 2024-03-25 |
| Record revised | 2022-10-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.; Special storage condition: Keep away from sunlight |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 6 to 8 Fr; length 45 to 110 cm; catheter length 47 to 110 cm |
| Distribution end date | 2025-10-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB6FR35 | Catheter Length 100.0 cm | In distribution |
| SB7SL45SH | Curve SL4.5 SH | In distribution |
| SB6AL20SH | Curve Description: SH | In distribution |
| SB6IMASHD | Length 90.0 cm | In distribution |
| SB6ERADLSH | Catheter Gauge 6.0 Fr | In distribution |
| SB6SR30 | Curve SR3.0 | In distribution |
| SB6HSID | Catheter Gauge 6.0 Fr | In distribution |
| SB7JR45 | Curve Description: JR4.5 | In distribution |
| SB6AR20 | Catheter Gauge 6.0 Fr | In distribution |
| SB6SR35 | Length 100.0 cm | In distribution |
| SB6JR45 | Curve Description: JR4.5 | In distribution |
| SB6SR40 | Catheter Gauge 6.0 Fr | In distribution |
| SB6JL30SH | Curve Description: SH | In distribution |
| SB7SCR50 | Catheter Gauge 7.0 Fr | In distribution |
| SB8MP1 | Catheter Gauge 8.0 Fr | In distribution |
| SB6HSI | Catheter Gauge 6.0 Fr | In distribution |
| SB7IMAK | Catheter Gauge 7.0 Fr | In distribution |
| SB6SL50SH | Curve Description: SL5.0 | In distribution |
| SB6SL35SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6AL75 | Length 100.0 cm | In distribution |
| SB7MPST | Catheter Gauge 7.0 Fr | In distribution |
| SB63DRCSH | Curve 3DRC SH | In distribution |
| SB73DRC | Catheter Gauge 7.0 Fr | In distribution |
| SB6EBU375 | Catheter Gauge 6.0 Fr | In distribution |
| SB6JR60 | Curve JR6.0 | In distribution |
| SB6SAR20 | Curve Description: SAR2.0 | In distribution |
| SB7EBU40D | Length 90.0 cm | In distribution |
| SB6RBU35SH | Curve RBU3.5 SH | In distribution |
| SB7JR45SH | Curve JR4.5 SH | In distribution |
| SB6AL30 | Curve Description: AL3.0 | In distribution |
| SB7CHAMP20SH | Curve Description: CHAMP2.0 | In distribution |
| SB6ALR12SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCL40SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6ECR35SH | Curve ECR3.5 SH | In distribution |
| SB6SR50 | Catheter Length 100.0 cm | In distribution |
| SB7CHAMP15SH | Curve Description: SH | In distribution |
| SB6AL30SH | Length 100.0 cm | In distribution |
| SB8IMASHD | Length 90.0 cm | In distribution |
| SB7JL45 | Curve Description: JL4.5 | In distribution |
| SB6ECR45 | Curve ECR4.5 | In distribution |
| SB6IMA | Catheter Gauge 6.0 Fr | In distribution |
| SB7SAL20 | Catheter Length 100.0 cm | In distribution |
| SB6JR50SH | Catheter Gauge 6.0 Fr | In distribution |
| SB7AR20SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6IMASH | Catheter Gauge 6.0 Fr | In distribution |
| SB6SAL75SH | Length 100.0 cm | In distribution |
| SB6IMAIISHD | Curve IMAII SH | In distribution |
| SB7MP1SH | Length 100.0 cm | In distribution |
| SB7SL35SH | Curve Description: SH | In distribution |
| SB7SAL10SH | Catheter Gauge 7.0 Fr | In distribution |
| SB7MAC40 | Curve Description: MAC4.0 | In distribution |
| SB7MAC35SH | Curve MAC3.5 SH | In distribution |
| SB6SL30 | Curve Description: SL3.0 | In distribution |
| SB6AL10 | Catheter Gauge 6.0 Fr | In distribution |
| SB6ECR40SH | Catheter Length 100.0 cm | In distribution |
| SB6HSISH | Curve HSI SH | In distribution |
| SB6EBU45 | Curve EBU4.5 | In distribution |
| SB6SAR20 | Curve SAR2.0 | In distribution |
| SB6ERADLLT | Catheter Length 100.0 cm | In distribution |
| SB6JCL30 | Catheter Gauge 6.0 Fr | In distribution |
| SB7JL40D | Catheter Length 90.0 cm | In distribution |
| SB6EBU35A | Length 110.0 cm | In distribution |
| SB6ERADLSTSH | Catheter Gauge 6.0 Fr | In distribution |
| SB7AR20 | Curve AR2.0 | In distribution |
| SB6MP1SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6JL40A | Catheter Gauge 6.0 Fr | In distribution |
| SB7LCB | Catheter Gauge 7.0 Fr | In distribution |
| SB6RBU40 | Catheter Gauge 6.0 Fr | In distribution |
| SB7HSISH | Curve Description: HSI | In distribution |
| SB6SAL15 | Catheter Gauge 6.0 Fr | In distribution |
| SB6SAR10 | Catheter Length 100.0 cm | In distribution |
| SB6JR40 | Catheter Gauge 6.0 Fr | In distribution |
| SB6AL10 | Curve Description: AL1.0 | In distribution |
| SB6ECR35 | Curve ECR3.5 | In distribution |
| SB7IMAD | Catheter Gauge 7.0 Fr | In distribution |
| SB6SAL40 | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCL30SH | Length 100.0 cm | In distribution |
| SB6SCR40 | Length 100.0 cm | In distribution |
| SB6ERADRSH | Catheter Gauge 6.0 Fr | In distribution |
| SB7JL50SH | Curve JL5.0 SH | In distribution |
| SB6CHAMP20 | Curve CHAMP2.0 | In distribution |
| SB7AL75SH | Catheter Gauge 7.0 Fr | In distribution |
| SB7MB1SH | Length 100.0 cm | In distribution |
| SB7ALR12 | Catheter Gauge 7.0 Fr | In distribution |
| SB6JL35SH | Length 100.0 cm | In distribution |
| SB7JL40 | Catheter Gauge 7.0 Fr | In distribution |
| SB6ECR30 | Length 100.0 cm | In distribution |
| SB7SL35SH | Curve SL3.5 SH | In distribution |
| SB6SR35SH | Curve Description: SR3.5 | In distribution |
| SB6SAL10SH | Length 100.0 cm | In distribution |
| SB7JL30 | Catheter Gauge 7.0 Fr | In distribution |
| SB6PK1W | Catheter Gauge 6.0 Fr | In distribution |
| SB6JR40D | Curve JR4.0 | In distribution |
| SB6AL20SH | Curve AL2.0 SH | In distribution |
| SB6CHAMP30 | Catheter Length 100.0 cm | In distribution |
| SB6MB1D | Catheter Length 90.0 cm | In distribution |
| SB6JL40PSH | Curve Description: SH | In distribution |
| SB7MAC35SH | Catheter Gauge 7.0 Fr | In distribution |
| SB7AL10SH | Curve Description: AL1.0 | In distribution |
| SB7EBU375SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6JCR35SH | Length 100.0 cm | In distribution |
| SB6MAC45 | Catheter Gauge 6.0 Fr | In distribution |
| SB6SCR40SH | Curve SCR4.0 SH | In distribution |
| SB7AR20SH | Curve AR2.0 SH | In distribution |
| SB7EBU375 | Curve EBU3.75 | In distribution |
| SB6FR40SH | Curve FR4.0 SH | In distribution |
| SB6ERADL | Catheter Gauge 6.0 Fr | In distribution |
| SB6ECR30 | Curve Description: ECR3.0 | In distribution |
| SB7RDCK | Curve RDC | In distribution |
| SB6AL10SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6JR40SH | Curve Description: JR4.0 | In distribution |
| SB7CHAMP05SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6JCR40 | Catheter Gauge 6.0 Fr | In distribution |
| SB6CHAMP20SH | Curve Description: SH | In distribution |
| SB73DRIGHTSH | Length 100.0 cm | In distribution |
| SB7EBU30 | Catheter Gauge 7.0 Fr | In distribution |
| SB6MB1 | Catheter Gauge 6.0 Fr | In distribution |
| SB6EBU35SH | Curve EBU3.5 SH | In distribution |
| SB6AL20A | Catheter Gauge 6.0 Fr | In distribution |
| SB7HSI | Length 100.0 cm | In distribution |
| SB6MAC30 | Curve Description: MAC3.0 | In distribution |
| SB6FR40SH | Curve Description: SH | In distribution |
| SB6MAC3030 | Catheter Gauge 6.0 Fr | In distribution |
| SB6MPHK | Catheter Gauge 6.0 Fr | In distribution |
| SB7EBU40SH | Curve Description: SH | In distribution |
| SB6SL45SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCR40 | Curve Description: JCR4.0 | In distribution |
| SB6MAC45 | Catheter Gauge 6.0 Fr | In distribution |
| SB6MP1A | Curve MP1 | In distribution |
| SB6IMAD | Catheter Gauge 6.0 Fr | In distribution |
| SB6EBU375 | Curve EBU3.75 | In distribution |
| SB6JL40A | Curve Description: JL4.0 | In distribution |
| SB7JL60SH | Curve Description: JL6.0 | In distribution |
| SB7IMA | Curve Description: IMA | In distribution |
| SB7SCR35 | Curve SCR3.5 | In distribution |
| SB6AR10A | Length 110.0 cm | In distribution |
| SB6MB2SH | Catheter Gauge 6.0 Fr | In distribution |
| SB7CHAMP15SH | Length 100.0 cm | In distribution |
| SB7ECR40 | Catheter Gauge 7.0 Fr | In distribution |
| SB7SR40SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6EBU40SH | Length 100.0 cm | In distribution |
| SB6JR40 | Curve JR4.0 | In distribution |
| SB73DRIGHT | Curve 3DRIGHT | In distribution |
| SB6JL50A | Length 110.0 cm | In distribution |
| SB7LCBSH | Catheter Gauge 7.0 Fr | In distribution |
| SB7EBUL375SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6IMA | Catheter Length 100.0 cm | In distribution |
| SB6MAC40 | Curve Description: MAC4.0 | In distribution |
| SB7SAL75 | Curve Description: SAL.75 | In distribution |
| SB6SR40SH | Curve Description: SH | In distribution |
| SB7LCBSH | Catheter Gauge 7.0 Fr | In distribution |
| SB7JL35 | Catheter Gauge 7.0 Fr | In distribution |
| SB63DRIGHTSH | Curve 3DRIGHT SH | In distribution |
| SB7MAC30SH | Curve Description: MAC3.0 | In distribution |
| SB6SAR20SH | Curve Description: SAR2.0 | In distribution |
| SB6ALR12SH | Catheter Length 100.0 cm | In distribution |
| SB7SAL20SH | Length 100.0 cm | In distribution |
| SB6JL40 | Curve JL4.0 | In distribution |
| SB6MP1K | Length 55.0 cm | In distribution |
| SB6MPST | Length 100.0 cm | In distribution |
| SB6SL35 | Curve Description: SL3.5 | In distribution |
| SB7RBU35SH | Catheter Length 100.0 cm | In distribution |
| SB6EBU40A | Catheter Length 110.0 cm | In distribution |
| SB7SAL75SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6SAL10SH | Curve Description: SAL1.0 | In distribution |
| SB7HSII | Length 100.0 cm | In distribution |
| SB6JR405 | Length 100.0 cm | In distribution |
| SB7RBU35 | Curve RBU3.5 | In distribution |
| SB7MP1 | Catheter Length 100.0 cm | In distribution |
| SB6MAC375 | Catheter Gauge 6.0 Fr | In distribution |
| SB7MB1 | Curve MB1 | In distribution |
| SB6JR35 | Catheter Length 100.0 cm | In distribution |
| SB6RMHSII | Catheter Gauge 6.0 Fr | In distribution |
| SB6EBU40 | Length 100.0 cm | In distribution |
| SB6MB1SHD | Curve MB1 SH | In distribution |
| SB7EBU35SH | Curve Description: EBU3.5 | In distribution |
| SB63DRIGHT | Curve Description: 3DRIGHT | In distribution |
| SB6FR40 | Catheter Gauge 6.0 Fr | In distribution |
| SB6SR35 | Catheter Gauge 6.0 Fr | In distribution |
| SB7JL40SH | Length 100.0 cm | In distribution |
| SB6CHAMP40SH | Catheter Gauge 6.0 Fr | In distribution |
| SB7EBU40 | Curve EBU4.0 | In distribution |
| SB6JL60SH | Length 100.0 cm | In distribution |
| SB6JR45SH | Curve JR4.5 SH | In distribution |
| SB7MB2SH | Curve MB2 SH | In distribution |
| SB6SL35 | Length 100.0 cm | In distribution |
| SB7EBU40D | Catheter Gauge 7.0 Fr | In distribution |
| SB6LCBD | Catheter Gauge 6.0 Fr | In distribution |
| SB6JR40SHA | Curve JR4.0 SH | In distribution |
| SB6JL60SH | Catheter Length 100.0 cm | In distribution |
| SB7EBU30SH | Curve Description: EBU3.0 | In distribution |
| SB6AL75SH | Curve Description: AL.75 | In distribution |
| SB63DRCSH | Curve Description: SH | In distribution |
| SB7RCB | Curve RCB | In distribution |
| SB6PK1W | Curve Description: 47CM | In distribution |
| SB6JL45 | Curve JL4.5 | In distribution |
| SB6AL20 | Curve Description: AL2.0 | In distribution |
| SB6RCB | Catheter Gauge 6.0 Fr | In distribution |
| SB7ECR40 | Curve ECR4.0 | In distribution |
| SB6JCL35SH | Curve Description: JCL3.5 | In distribution |
| SB6MB1SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCL40SH | Catheter Gauge 6.0 Fr | In distribution |
| SB6NOTOSH | Catheter Gauge 6.0 Fr | In distribution |
| SB6ERADR | Length 100.0 cm | In distribution |
| SB7SL40 | Catheter Gauge 7.0 Fr | In distribution |
| SB6RCBII | Curve RCBII | In distribution |
| SB6JR60SH | Curve JR6.0 SH | In distribution |
| SB6MAC30SH | Length 100.0 cm | In distribution |
| SB6EBU40A | Length 110.0 cm | In distribution |
| SB7SCR35SH | Curve SCR3.5 SH | In distribution |
| SB6CHAMP30 | Curve CHAMP3.0 | In distribution |
| SB6CHAMP15SH | Curve Description: SH | In distribution |
| SB6JCL35SH | Length 100.0 cm | In distribution |
| SB6MAC35 | Curve Description: MAC3.5 | In distribution |
| SB6EBU375 | Catheter Gauge 6.0 Fr | In distribution |
| SB7ECR45 | Curve ECR4.5 | In distribution |
| SB7JCL35SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6JR50A | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCL45 | Catheter Gauge 6.0 Fr | In distribution |
| SB7SAL75SH | Catheter Gauge 7.0 Fr | In distribution |
| SB6FR40 | Catheter Length 100.0 cm | In distribution |
| SB6MP1K | Catheter Gauge 6.0 Fr | In distribution |
| SB6EBU45D | Catheter Gauge 6.0 Fr | In distribution |
| SB6JCL50 | Catheter Gauge 6.0 Fr | In distribution |
| SB7CHAMP15 | Curve CHAMP1.5 | In distribution |
| SB6SAL20 | Catheter Gauge 6.0 Fr | In distribution |
| SB6JL50 | Curve Description: JL5.0 | In distribution |
| SB7JR50SH | Curve Description: JR5.0 | In distribution |
| SB6EBU35 | Curve EBU3.5 | In distribution |
| SB7AL10 | Curve Description: AL1.0 | In distribution |
| SB6SR50SH | Curve Description: SR5.0 | In distribution |
| SB6JL45SH | Catheter Gauge 6.0 Fr | In distribution |
| SB7MAC40SH | Curve Description: MAC4.0 | In distribution |
| SB6SL35SH | Curve Description: SH | In distribution |
| SB6JR30SH | Curve JR3.0 SH | In distribution |
| SB7IMA | Length 100.0 cm | In distribution |
| SB6MP2 | Catheter Gauge 6.0 Fr | In distribution |
| SB6JR45 | Curve JR4.5 | In distribution |
| SB6ERADLLT | Curve ERAD LEFT LONG TIP | In distribution |
| SB6SAL10 | Catheter Gauge 6.0 Fr | In distribution |
| SB6CHAMP15SH | Curve CHAMP1.5 SH | In distribution |
| SB7SCR40 | Catheter Gauge 7.0 Fr | In distribution |
| SB6MP1 | Catheter Gauge 6.0 Fr | In distribution |
| SB6AL15SH | Curve Description: AL1.5 | In distribution |
| SB6RRAD | Catheter Gauge 6.0 Fr | In distribution |
| SB6RDCK | Curve Description: 55CM | In distribution |
| SB7RCBSH | Catheter Gauge 7.0 Fr | In distribution |
| SB6AL15 | Catheter Length 100.0 cm | In distribution |
| SB6AL30SH | Curve Description: SH | In distribution |
| SB6IMAK | Catheter Length 55.0 cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
| Wiseguide™ | Boston Scientific Corporation | 277 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253409 | 2025-12-19 |
| K250558 | 2025-03-27 |
| K223178 | 2022-11-08 |
| K222873 | 2022-11-07 |
| K192712 | 2020-08-03 |
| K183353 | 2019-03-22 |
| K183493 | 2019-03-15 |
| K132673 | 2013-10-22 |
| K121219 | 2012-09-25 |
| K112917 | 2011-10-27 |
| K103386 | 2011-02-11 |
| K101885 | 2010-09-09 |
| K090659 | 2009-03-26 |
| K080428 | 2008-12-09 |
| K082670 | 2008-12-04 |
Recalls Naming This Product
191 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 1226 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 658 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 538 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 12 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 4 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 1 unit | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 12 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 1491 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 655 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 1701 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 221 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 29 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 6 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 5 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 18 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 2 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 17 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 20 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 9 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 215 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 14 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 555 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 53 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 42 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 2 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 27 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 12 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 22 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 14 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 12 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 10 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 5 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 39 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 2 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 6 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 0 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 8 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 20 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 4 units | 2024-04-26 |
| Medtronic Vascular | 510(k) number | 2019-03-15 | Class I | Component design/selection | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | 10 units | 2024-04-26 |
Showing 40 of 191.
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-04-20 | Class II | Under Investigation by firm | The firm’s internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. | 1385 devices | |
| 2021-09-09 | Class II | Under Investigation by firm | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. | 591 units | |
| 2017-09-26 | Class I | Nonconforming Material/Component | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | 15,923 | 2021-04-27 |
| 2013-06-12 | Class II | Labeling mix-ups | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package. | 15 | 2013-11-19 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2002-11-25 | Not classified | Other | An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances. | 775 units | 2003-11-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.