Sherpa NX Active
Catheter SA5JL60 SA 5F JL6.0 100CM JL60
14manufacturers in China registered for this device type
571catalogue 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) | K042489 |
| Record published | 2016-05-30 |
| Record revised | 2022-09-05 (version 10) |
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 catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Packaging | Pack of 5 |
| Sizes | Length 45 to 110 cm; catheter gauge 5 to 6 Fr |
| Distribution end date | 2020-06-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA6SAL10 | Curve SAL1.0 | In distribution |
| SA6EBU375SH | Length 100.0 cm | In distribution |
| SA5JL45 | Length 100.0 cm | In distribution |
| SA6EBU375 | Length 100.0 cm | In distribution |
| SA6HSISH | Length 100.0 cm | In distribution |
| SA6SAL20SH | Length 100.0 cm | In distribution |
| SA6JR35 | Length 100.0 cm | In distribution |
| SA6RBU35 | Catheter Gauge 6.0 Fr | In distribution |
| SA6EBU45SH | Curve EBU4.5 SH | In distribution |
| SA6JR40 | Catheter Gauge 6.0 Fr | In distribution |
| SA6EBU30 | Catheter Gauge 6.0 Fr | In distribution |
| SA6JL40 | Catheter Gauge 6.0 Fr | In distribution |
| SA6SL50SH | Catheter Gauge 6.0 Fr | In distribution |
| SA6JCL50 | Curve JCL5.0 | In distribution |
| SA6HSI | Length 100.0 cm | Withdrawn |
| SA6FL40G | Curve FL4.0G | Withdrawn |
| SA6SAL15 | Curve SAL1.5 | Withdrawn |
| SA5MODHSII | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5FL60 | Length 100.0 cm | Withdrawn |
| SA5SL40 | Length 100.0 cm | Withdrawn |
| SA5SL35 | Curve SL3.5 | Withdrawn |
| SA6LCBSH | Curve LCB SH | Withdrawn |
| SA5JL60 | Curve JL6.0 | Withdrawn |
| SA6IMAK | Curve IMA | Withdrawn |
| SA6ARA7515 | Length 100.0 cm | Withdrawn |
| SA6JR40 | Curve JR4.0 | Withdrawn |
| SA6AR20 | Length 100.0 cm | Withdrawn |
| SA5FR30 | Length 100.0 cm | Withdrawn |
| SA6AR10 | Length 100.0 cm | Withdrawn |
| SA5JCR35 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBU35A | Length 110.0 cm | Withdrawn |
| SA5ERADL | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6JCL50 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5VDL1 | Length 100.0 cm | Withdrawn |
| SA6CHAMP40 | Length 100.0 cm | Withdrawn |
| SA6VDL13 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JR40K | Length 55.0 cm | Withdrawn |
| SA5AL75 | Curve AL.75 | Withdrawn |
| SA6RDCV | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL40PSH | Curve JL4.0P SH | Withdrawn |
| SA6FR35 | Curve FR3.5 | Withdrawn |
| SA6ERADLSH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6EBU40SHD | Length 90.0 cm | Withdrawn |
| SA5AR105 | Curve AR1.0 | Withdrawn |
| SA6RCBII | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6LCB | Catheter Gauge 6.0 Fr | Withdrawn |
| SA63DRIGHT | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC3030SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5EBU50 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5FL40 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5JL50A | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6AR205 | Length 100.0 cm | Withdrawn |
| SA6JR40SHD | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5JR50 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5HSII | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5SCR50 | Length 100.0 cm | Withdrawn |
| SA5JR50A | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5RLTJR40 | Length 100.0 cm | Withdrawn |
| SA6CHAMP30SH | Length 100.0 cm | Withdrawn |
| SA53DRIGHT | Curve 3D RIGHT | Withdrawn |
| SA6MAC30SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6HSIIISH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6AL20 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6AL75 | Curve AL.75 | Withdrawn |
| SA5JR35 | Curve JR3.5 | Withdrawn |
| SA6JR35 | Length 100.0 cm | Withdrawn |
| SA6RBU40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5CHAMP05 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBU35SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6RBU35SH | Length 100.0 cm | Withdrawn |
| SA6HSIISH | Curve HSII SH | Withdrawn |
| SA6AR20 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL45 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5MAC375 | Curve MAC3.75 | Withdrawn |
| SA6JL30SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6AL30A | Length 110.0 cm | Withdrawn |
| SA6JCL35SH | Length 100.0 cm | Withdrawn |
| SA6MP2 | Curve MP2 | Withdrawn |
| SA5MAC30 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6JL50 | Curve JL5.0 | Withdrawn |
| SA5JR35 | Curve JR3.5 | Withdrawn |
| SA6SAL15SH | Length 100.0 cm | Withdrawn |
| SA5SR60 | Length 100.0 cm | Withdrawn |
| SA6RBU35 | Curve RBU3.5 | Withdrawn |
| SA6ERADL | Length 100.0 cm | Withdrawn |
| SA6HSIISH | Length 100.0 cm | Withdrawn |
| SA5JR40 | Curve JR4.0 | Withdrawn |
| SA6MAC50 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6SR50 | Length 100.0 cm | Withdrawn |
| SA6CHAMP30 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6CHAMP25SH | Length 100.0 cm | Withdrawn |
| SA5AR10 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBU40 | Length 100.0 cm | Withdrawn |
| SA6IMAV | Length 45.0 cm | Withdrawn |
| SA5AR20 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6JCL45 | Length 100.0 cm | Withdrawn |
| SA5MAC45 | Curve MAC4.5 | Withdrawn |
| SA6AL205 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6ERADRST | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6EBUL30 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5RAD1 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5FR45 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5AL10 | Length 100.0 cm | Withdrawn |
| SA6SAL25SH | Length 100.0 cm | Withdrawn |
| SA5SAR20 | Curve SAR2.0 | Withdrawn |
| SA6RDCK | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JR405 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MRESS | Length 100.0 cm | Withdrawn |
| SA5JR40A | Length 110.0 cm | Withdrawn |
| SA5JCL40 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA63DMIGISH | Curve 3D MIGI SH | Withdrawn |
| SA6JL50A | Length 110.0 cm | Withdrawn |
| SA5RCB | Curve RCB | Withdrawn |
| SA5SCR35 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5JCL30 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA5MB1 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBU355 | Length 100.0 cm | Withdrawn |
| SA6ALR12 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC2520 | Curve MAC2.5 20° | Withdrawn |
| SA5IMAJ | Length 60.0 cm | Withdrawn |
| SA6JL40SHA | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL40SH | Curve JL4.0 SH | Withdrawn |
| SA6ELGAMAL | Curve EL GAMAL | Withdrawn |
| SA5IMAA | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBU455 | Curve EBU4.5 | Withdrawn |
| SA6SR45 | Length 100.0 cm | Withdrawn |
| SA6SCR40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6SAL20 | Length 100.0 cm | Withdrawn |
| SA6IMASH | Length 100.0 cm | Withdrawn |
| SA5SL60 | Length 100.0 cm | Withdrawn |
| SA5ERADLLT | Length 100.0 cm | Withdrawn |
| SA6SL30 | Curve SL3.0 | Withdrawn |
| SA5MPST | Length 100.0 cm | Withdrawn |
| SA5RRAD | Curve RRAD | Withdrawn |
| SA6JR40A | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6ECR35 | Length 100.0 cm | Withdrawn |
| SA5LARA | Curve LARA | Withdrawn |
| SA6HSII | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6ECR30 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JR35SHD | Length 90.0 cm | Withdrawn |
| SA5SAL10 | Length 100.0 cm | Withdrawn |
| SA6RDND1K | Curve RDND1 | Withdrawn |
| SA6SL60SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5JR355 | Curve JR3.5 | Withdrawn |
| SA6AL15 | Curve AL1.5 | Withdrawn |
| SA6HSIV | Curve HSI | Withdrawn |
| SA6SCR35 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC40 | Curve MAC4.0 | Withdrawn |
| SA6CHAMP20 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6FR40 | Curve FR4.0 | Withdrawn |
| SA6SCR40SH | Length 100.0 cm | Withdrawn |
| SA5EBU375 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6SAL10 | Length 100.0 cm | Withdrawn |
| SA5PAPA1 | Curve PAPA1 | Withdrawn |
| SA6JR45 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6HUG3045 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MB2SH | Length 100.0 cm | Withdrawn |
| SA6FL40GSH | Curve FL4.0G SH | Withdrawn |
| SA5JL40 | Curve JL4.0 | Withdrawn |
| SA6CHAMP20SH | Length 100.0 cm | Withdrawn |
| SA6JCR35 | Curve JCR3.5 | Withdrawn |
| SA6AL30 | Curve AL3.0 | Withdrawn |
| SA6MPHK | Length 55.0 cm | Withdrawn |
| SA5RBU35 | Length 100.0 cm | Withdrawn |
| SA5CHAMP30 | Length 100.0 cm | Withdrawn |
| SA6JR35D | Curve JR3.5 | Withdrawn |
| SA6FR40SH | Length 100.0 cm | Withdrawn |
| SA6EBUL375 | Length 100.0 cm | Withdrawn |
| SA6MPST | Catheter Gauge 6.0 Fr | Withdrawn |
| SA63DRCSH | Curve 3DRC SH | Withdrawn |
| SA6JL50SH | Length 100.0 cm | Withdrawn |
| SA6JL40MOD | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5EBU20 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6RBU45 | Length 100.0 cm | Withdrawn |
| SA63DRC | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6ERADLSTSH | Curve ERAD LEFT SHORT TIP SH | Withdrawn |
| SA6AR10A | Length 110.0 cm | Withdrawn |
| SA6JR40MOD | Length 100.0 cm | Withdrawn |
| SA6NOTOSH | Curve NOTO SH | Withdrawn |
| SA6ELGAMALSH | Length 100.0 cm | Withdrawn |
| SA6RBU40SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL30 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6ALR12SH | Curve ALR1-2 SH | Withdrawn |
| SA5MAC35 | Curve MAC3.5 | Withdrawn |
| SA6SAL20 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JR50 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5ELGAMAL | Curve EL GAMAL | Withdrawn |
| SA5JCR40 | Length 100.0 cm | Withdrawn |
| SA6AL20A | Curve AL2.0 | Withdrawn |
| SA6EBU45SH | Length 100.0 cm | Withdrawn |
| SA6LARA | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL35 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6RBU40V | Curve RBU4.0 | Withdrawn |
| SA5SAL20 | Curve SAL2.0 | Withdrawn |
| SA6ARA9015SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5AR20 | Curve AR2.0 | Withdrawn |
| SA5AR205 | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6FL40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6EBU375SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC35 | Length 100.0 cm | Withdrawn |
| SA6ARA7526 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JL405 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6LCBSHD | Curve LCB SH | Withdrawn |
| SA6IMASHD | Length 90.0 cm | Withdrawn |
| SA63DRIGHTSH | Length 100.0 cm | Withdrawn |
| SA5JCL35 | Length 100.0 cm | Withdrawn |
| SA6AL25SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6EBU30 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5RAD2 | Curve RAD2 | Withdrawn |
| SA5MB2 | Length 100.0 cm | Withdrawn |
| SA6JL45 | Length 100.0 cm | Withdrawn |
| SA5NOTO | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6EBUL30SH | Length 100.0 cm | Withdrawn |
| SA5MRADIAL | Catheter Gauge 5.0 Fr | Withdrawn |
| SA6MP1SH | Curve MP1 SH | Withdrawn |
| SA6SR40SH | Length 100.0 cm | Withdrawn |
| SA6FL40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC45 | Curve MAC4.5 | Withdrawn |
| SA63DRIGHT | Curve 3DRIGHT | Withdrawn |
| SA6AL15SH | Curve AL1.5 SH | Withdrawn |
| SA6EBU45 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5MRESS | Curve MRESS | Withdrawn |
| SA6JR35A | Length 110.0 cm | Withdrawn |
| SA6HSIII | Length 100.0 cm | Withdrawn |
| SA5PAPA | Length 100.0 cm | Withdrawn |
| SA6AL75A | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5RCBD | Curve RCB | Withdrawn |
| SA6LCBSH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5RBU40 | Length 100.0 cm | Withdrawn |
| SA6JL355 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6SL40SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6SL35 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6EBU35 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC35 | Curve MAC3.5 | Withdrawn |
| SA6JCL45SH | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6SCR40K | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6JCL40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6CHAMP20K | Catheter Gauge 6.0 Fr | Withdrawn |
| SA5SR30 | Curve SR3.0 | Withdrawn |
| SA6AR20SH | Length 100.0 cm | Withdrawn |
| SA6SAL10SH | Curve SAL1.0 SH | Withdrawn |
| SA6SL30SH | Length 100.0 cm | Withdrawn |
| SA5SAL15 | Length 100.0 cm | Withdrawn |
| SA6JR40SHA | Length 110.0 cm | Withdrawn |
| SA6SR50 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6IMAK | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6RCB | Curve RCB | Withdrawn |
| SA6SL35SH | Curve SL3.5 SH | Withdrawn |
| SA6SAL40 | Catheter Gauge 6.0 Fr | Withdrawn |
| SA6MAC30 | Curve MAC3.0 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| 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.