Zuma®
Catheter ZS8ARAN7515SH ZM 8F 100CM A7515
14manufacturers in China registered for this device type
569catalogue 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) | K982883 |
| Record published | 2016-04-22 |
| Record revised | 2023-08-02 (version 8) |
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 47 to 110 cm; catheter gauge 6 to 9 Fr |
| Distribution end date | 2020-06-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZS8EBU45SH | Curve EBU4.5 SH | Withdrawn |
| ZS8EBU40 | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6SAR10SH | Length 100.0 cm | Withdrawn |
| ZT7FL45SH | Curve FL4.5 SH | Withdrawn |
| ZM6SAL20 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6AL30 | Curve AL3.0 | Withdrawn |
| ZT7JR30SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZT7FL30SH | Length 100.0 cm | Withdrawn |
| ZT7JR50SH | Curve JR5.0 SH | Withdrawn |
| ZM6SL30 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7SL50SH | Curve SL5.0 SH | Withdrawn |
| ZM6SL40SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7JL40A | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6SAL75SH | Length 100.0 cm | Withdrawn |
| ZT7RCBSH | Curve RCB SH | Withdrawn |
| ZM9EBU40 | Length 100.0 cm | Withdrawn |
| ZM6IMAJ | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6RCB | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7SL40 | Curve SL4.0 | Withdrawn |
| ZT7SCR35 | Curve SCR3.5 | Withdrawn |
| ZM6FR35 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6ALR12SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7JCL40 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZS8FL50 | Curve FL5.0 | Withdrawn |
| ZM9EBU40SH | Catheter Gauge 9.0 Fr | Withdrawn |
| ZS8AL25SH | Length 100.0 cm | Withdrawn |
| ZM6FR40 | Length 100.0 cm | Withdrawn |
| ZS8FL40 | Length 100.0 cm | Withdrawn |
| ZS8JL60SH | Length 100.0 cm | Withdrawn |
| ZM9EBU375 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZT7ALR12 | Length 100.0 cm | Withdrawn |
| ZT7JCL35 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6FL35SH | Curve FL3.5 SH | Withdrawn |
| ZS8EBU35SH | Curve EBU3.5 SH | Withdrawn |
| ZT7SAL10 | Curve SAL1.0 | Withdrawn |
| ZS8JL35SH | Length 100.0 cm | Withdrawn |
| ZM9JR60SH | Curve JR6.0 SH | Withdrawn |
| ZM6JCR35SH | Curve JCR3.5 SH | Withdrawn |
| ZM6SCR35 | Curve SCR3.5 | Withdrawn |
| ZM6MAC35 | Length 100.0 cm | Withdrawn |
| ZM6SL50SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7JL30 | Length 100.0 cm | Withdrawn |
| ZS8SAL20SH | Curve SAL2.0 SH | Withdrawn |
| ZM6DC40 | Curve DC4.0 | Withdrawn |
| ZM6SAL10 | Curve SAL1.0 | Withdrawn |
| ZM6CHAMP20 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM9AL30 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZS8SR40SH | Catheter Gauge 8.0 Fr | Withdrawn |
| ZT7RCB | Catheter Gauge 7.0 Fr | Withdrawn |
| ZS8JR35SH | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6MULTIA1 | Curve MULTI A-1 | Withdrawn |
| ZM9AL75 | Length 100.0 cm | Withdrawn |
| ZM6JL50 | Length 100.0 cm | Withdrawn |
| ZS8CHAMP10 | Catheter Gauge 8.0 Fr | Withdrawn |
| ZT7JCL50 | Curve JCL5.0 | Withdrawn |
| ZM9ELGAMAL | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM9EBU375SH | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM9IMA | Curve IMA | Withdrawn |
| ZS8JR40 | Length 100.0 cm | Withdrawn |
| ZT7HSISH | Length 100.0 cm | Withdrawn |
| ZM9MB1SH | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM6SR50 | Length 100.0 cm | Withdrawn |
| ZM9AR10 | Curve AR1.0 | Withdrawn |
| ZM6FL60SH | Curve FL6.0 SH | Withdrawn |
| ZS8MB1SH | Length 100.0 cm | Withdrawn |
| ZM9HSISHD | Curve HSI SH | Withdrawn |
| ZS8EBU50SH | Curve EBU5.0 SH | Withdrawn |
| ZT7FR45SH | Curve FR4.5 SH | Withdrawn |
| ZM6HSISH | Length 100.0 cm | Withdrawn |
| ZT7FR40SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6SR45SH | Length 100.0 cm | Withdrawn |
| ZM9V1M | Curve V1 | Withdrawn |
| ZT7AL75SH | Length 100.0 cm | Withdrawn |
| ZM6JCL40SH | Length 100.0 cm | Withdrawn |
| ZM6AR10SH | Curve AR1.0 SH | Withdrawn |
| ZM6MB2SH | Length 100.0 cm | Withdrawn |
| ZM6MAC30 | Curve MAC3.0 | Withdrawn |
| ZM6JR35SH | Curve JR3.5 SH | Withdrawn |
| ZS8JL30SH | Curve JL3.0 SH | Withdrawn |
| ZM6SAR20 | Curve SAR2.0 | Withdrawn |
| ZT7JR60 | Length 100.0 cm | Withdrawn |
| ZS8MB2 | Length 100.0 cm | Withdrawn |
| ZM6HSIISH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6DC45 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7SAL15 | Curve SAL1.5 | Withdrawn |
| ZT7JL35 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZT7SAL20SH | Length 100.0 cm | Withdrawn |
| ZS8HSIII | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6SL50 | Length 100.0 cm | Withdrawn |
| ZM9EBU30 | Curve EBU3.0 | Withdrawn |
| ZM6SL40 | Length 100.0 cm | Withdrawn |
| ZT7SL45 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM9JR50 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM6SAL15SH | Length 100.0 cm | Withdrawn |
| ZM6JR40A | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM9JCL40SH | Curve JCL4.0 SH | Withdrawn |
| ZM9JCL40 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZS8HSIISH | Length 100.0 cm | Withdrawn |
| ZT7JL35SH | Length 100.0 cm | Withdrawn |
| ZT7EBU35SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6HSI | Curve HSI | Withdrawn |
| ZM6FR50SH | Curve FR5.0 SH | Withdrawn |
| ZT7AL25 | Length 100.0 cm | Withdrawn |
| ZM6SR30 | Curve SR3.0 | Withdrawn |
| ZT7JCR40 | Curve JCR4.0 | Withdrawn |
| ZS8SAL20 | Length 100.0 cm | Withdrawn |
| ZM6JL40A | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6AL75SH | Curve AL.75 SH | Withdrawn |
| ZM6JL30 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8JCL45 | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6SCR35SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM9JL40SH | Length 100.0 cm | Withdrawn |
| ZM6JL45SH | Curve JL4.5 SH | Withdrawn |
| ZS8NOTO | Length 100.0 cm | Withdrawn |
| ZM6FL50SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7JCL35SH | Length 100.0 cm | Withdrawn |
| ZS8JL30 | Length 100.0 cm | Withdrawn |
| ZM9JL30SH | Curve JL3.0 SH | Withdrawn |
| ZM6JL60 | Length 100.0 cm | Withdrawn |
| ZM6CHAMP15 | Curve CHAMP1.5 | Withdrawn |
| ZT7JR40SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6IMAD | Length 90.0 cm | Withdrawn |
| ZS8EBU40SH | Curve EBU4.0 SH | Withdrawn |
| ZM9IMASH | Length 100.0 cm | Withdrawn |
| ZM6RLXJCL40 | Length 100.0 cm | Withdrawn |
| ZS8RCBSHD | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6DC375 | Length 100.0 cm | Withdrawn |
| ZS8FR35SH | Length 100.0 cm | Withdrawn |
| ZM9FL40 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM9AR20 | Catheter Gauge 9.0 Fr | Withdrawn |
| ZT7SAL40 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZS8FL35SH | Curve FL3.5 SH | Withdrawn |
| ZS8JR40D | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6IMA | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8SL40 | Length 100.0 cm | Withdrawn |
| ZS8IMA | Catheter Gauge 8.0 Fr | Withdrawn |
| ZT7EBU30 | Length 100.0 cm | Withdrawn |
| ZM9JL45 | Curve JL4.5 | Withdrawn |
| ZM6EBU50 | Length 100.0 cm | Withdrawn |
| ZM6DC40A | Curve DC4.0 | Withdrawn |
| ZT7JR35SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZS8ELGAMAL | Curve EL GAMAL | Withdrawn |
| ZT7IMASHD | Length 90.0 cm | Withdrawn |
| ZM6JL45 | Curve JL4.5 | Withdrawn |
| ZM6JR40SHD | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6AR10A | Length 110.0 cm | Withdrawn |
| ZT7JR45 | Curve JR4.5 | Withdrawn |
| ZS8RCBSH | Curve RCB SH | Withdrawn |
| ZS8JCR40 | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM9JL50 | Length 100.0 cm | Withdrawn |
| ZT7JR35 | Length 100.0 cm | Withdrawn |
| ZM6AR20 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6HSIII | Length 100.0 cm | Withdrawn |
| ZM6JL40SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZT7RCBD | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM9JL45SH | Catheter Gauge 9.0 Fr | Withdrawn |
| ZS8AL75SH | Length 100.0 cm | Withdrawn |
| ZS8ARAN7515SH | Length 100.0 cm | Withdrawn |
| ZM9SR35 | Curve SR3.5 | Withdrawn |
| ZS8FL45SH | Curve FL4.5 SH | Withdrawn |
| ZM6SAL30 | Length 100.0 cm | Withdrawn |
| ZT7JL30SH | Curve JL3.0 SH | Withdrawn |
| ZS8AL20SH | Length 100.0 cm | Withdrawn |
| ZM6AR20A | Length 110.0 cm | Withdrawn |
| ZM6ALR12 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM6JL505 | Length 100.0 cm | Withdrawn |
| ZT7SCR40 | Curve SCR4.0 | Withdrawn |
| ZT7FL40 | Length 100.0 cm | Withdrawn |
| ZM6MAC35SH | Curve MAC3.5 SH | Withdrawn |
| ZS8SL45 | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM6MB1D | Curve MB1 | Withdrawn |
| ZM9SCR35SH | Curve SCR3.5 SH | Withdrawn |
| ZM6MAC30SH | Length 100.0 cm | Withdrawn |
| ZM6ARAN9026SH | Curve ARANI90/2.6 SH | Withdrawn |
| ZT7FR40 | Length 100.0 cm | Withdrawn |
| ZM6SR35 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8JL40 | Curve JL4.0 | Withdrawn |
| ZT7FR35 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM9JR50SH | Curve JR5.0 SH | Withdrawn |
| ZM6JL60SH | Curve JL6.0 SH | Withdrawn |
| ZS8AL75 | Curve AL.75 | Withdrawn |
| ZS8FL35 | Length 100.0 cm | Withdrawn |
| ZM9MB1 | Length 100.0 cm | Withdrawn |
| ZT7SAL75 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6AR10 | Length 100.0 cm | Withdrawn |
| ZT7AL15A | Curve AL1.5 | Withdrawn |
| ZT7AL30 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZS8IMASH | Length 100.0 cm | Withdrawn |
| ZM6EBU35 | Curve EBU3.5 | Withdrawn |
| ZS8IMASHD | Curve IMA SH | Withdrawn |
| ZT7FL35 | Curve FL3.5 | Withdrawn |
| ZS8CHAMP30 | Length 100.0 cm | Withdrawn |
| ZT7MB1SH | Curve MB1 SH | Withdrawn |
| ZM9AL20SH | Catheter Gauge 9.0 Fr | Withdrawn |
| ZT7JCL50SH | Length 100.0 cm | Withdrawn |
| ZT7AL20 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM9JR35 | Curve JR3.5 | Withdrawn |
| ZM6FL40SH | Length 100.0 cm | Withdrawn |
| ZM6FL40 | Curve FL4.0 | Withdrawn |
| ZM6AL25SH | Length 100.0 cm | Withdrawn |
| ZT7EBU375SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6JR40D | Length 90.0 cm | Withdrawn |
| ZM9HSIISH | Length 100.0 cm | Withdrawn |
| ZM6JR40 | Curve JR4.0 | Withdrawn |
| ZS8JCR35SH | Catheter Gauge 8.0 Fr | Withdrawn |
| ZS8SCR40 | Length 100.0 cm | Withdrawn |
| ZM6SAL75 | Length 100.0 cm | Withdrawn |
| ZM6JCL45 | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8EBU45 | Curve EBU4.5 | Withdrawn |
| ZM6AL10 | Curve AL1.0 | Withdrawn |
| ZS8JL45SH | Curve JL4.5 SH | Withdrawn |
| ZM9EBU50 | Length 100.0 cm | Withdrawn |
| ZM6MB1 | Curve MB1 | Withdrawn |
| ZT7AL20F | Curve AL2.0 | Withdrawn |
| ZM9LCBD | Curve LCB | Withdrawn |
| ZT7HSIISH | Curve HSII SH | Withdrawn |
| ZM6AR205 | Length 100.0 cm | Withdrawn |
| ZM6MAC40SH | Curve MAC4.0 SH | Withdrawn |
| ZT7JL45 | Curve JL4.5 | Withdrawn |
| ZS8ARAN9015SH | Length 100.0 cm | Withdrawn |
| ZM9JR45SH | Curve JR4.5 SH | Withdrawn |
| ZM9EBU50SH | Curve EBU5.0 SH | Withdrawn |
| ZM6NOTO | Curve NOTO | Withdrawn |
| ZM6CHAMP35 | Length 100.0 cm | Withdrawn |
| ZM9SCR40SH | Length 100.0 cm | Withdrawn |
| ZT7MB2 | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM9AL40 | Length 100.0 cm | Withdrawn |
| ZM9MAC40 | Curve MAC4.0 | Withdrawn |
| ZM6MB1SH | Curve MB1 SH | Withdrawn |
| ZM9SAR10 | Curve SAR1.0 | Withdrawn |
| ZS8MB1SHD | Length 90.0 cm | Withdrawn |
| ZT7AL25SH | Catheter Gauge 7.0 Fr | Withdrawn |
| ZM6EBU35SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8SCR35SH | Length 100.0 cm | Withdrawn |
| ZM6SAL20SH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZM9FL50SH | Curve FL5.0 SH | Withdrawn |
| ZT7AL15SH | Curve AL1.5 SH | Withdrawn |
| ZM6AL25 | Length 100.0 cm | Withdrawn |
| ZT7FR60 | Length 100.0 cm | Withdrawn |
| ZM6EBU35A | Length 110.0 cm | Withdrawn |
| ZM6SR60 | Length 100.0 cm | Withdrawn |
| ZM9IMAD | Catheter Gauge 9.0 Fr | Withdrawn |
| ZM9JCL45SH | Curve JCL4.5 SH | Withdrawn |
| ZM6LCBSH | Catheter Gauge 6.0 Fr | Withdrawn |
| ZS8HSISH | Catheter Gauge 8.0 Fr | Withdrawn |
| ZM9AL20 | Curve AL2.0 | Withdrawn |
| ZM6JCR35 | Curve JCR3.5 | Withdrawn |
| ZT7AR10A | Curve AR1.0 | Withdrawn |
| ZM6EBU45 | Length 100.0 cm | Withdrawn |
| ZS8JL45 | Curve JL4.5 | 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 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| 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
38 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 | 2011-06-08 | Not classified | Labeling Change Control | Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve | 5 units | 2012-04-17 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 22 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 22 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 13 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 28 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 7 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 16 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 12 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 18 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 75 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 31 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 55 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 31 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 17 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 6 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 14 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 22 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 104 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 36 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 8 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 17 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 17 35units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 35 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 37 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 14 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 44 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 51 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 51 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 21 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 10 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 20 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 8 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 9 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 14 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 21 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 139 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 577 units | 2007-06-20 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 8 units | 2007-06-20 |
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.