Z2
Catheter Z26ARAN9015SH Z2 6F 100CM A9015
14manufacturers in China registered for this device type
955catalogue 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) | K000677 |
| Record published | 2016-06-11 |
| Record revised | 2021-12-22 (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 45 to 110 cm; catheter gauge 5 to 8 Fr; outer diameter 2.06 mm; catheter inner diameter 1.78 mm |
| Distribution end date | 2024-09-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z27EBU40 | Length 100.0 cm | In distribution |
| Z26JCL50 | Length 100.0 cm | In distribution |
| Z26JR60 | Catheter Gauge 6.0 Fr | In distribution |
| Z26JR35SH | Length 100.0 cm | In distribution |
| Z27JL30 | Catheter Gauge 7.0 Fr | In distribution |
| Z26AR10A | Catheter Gauge 6.0 Fr | In distribution |
| Z28JR40SHA | Curve JR4.0 SH | In distribution |
| Z27JR40D | Catheter Gauge 7.0 Fr | In distribution |
| Z28AL10 | Length 100.0 cm | In distribution |
| Z27JL45SH | Curve JL4.5 SH | In distribution |
| Z28AL75SH | Catheter Gauge 8.0 Fr | In distribution |
| Z26JCL40SH | Catheter Gauge 6.0 Fr | In distribution |
| Z27SL40D | Length 90.0 cm | In distribution |
| Z28JL40D | Curve JL4.0 | In distribution |
| Z26MB1 | Length 100.0 cm | In distribution |
| Z26LCBSH | Length 100.0 cm | In distribution |
| Z27SL50 | Length 100.0 cm | In distribution |
| Z28EBU40D | Length 90.0 cm | In distribution |
| Z26SCR35SH | Curve SCR3.5 SH | In distribution |
| Z27EBU30D | Curve EBU3.0 | In distribution |
| Z26SCR40 | Catheter Gauge 6.0 Fr | In distribution |
| Z26FL45 | Catheter Gauge 6.0 Fr | In distribution |
| Z27AL30 | Length 100.0 cm | In distribution |
| Z27MB2 | Curve MB2 | In distribution |
| Z28JR35D | Length 90.0 cm | In distribution |
| Z26SCR35 | Curve SCR3.5 | In distribution |
| Z26RCBD | Catheter Gauge 6.0 Fr | In distribution |
| Z28RCB | Length 100.0 cm | In distribution |
| Z28EBU45SH | Curve EBU4.5 SH | In distribution |
| Z26MP2 | Length 100.0 cm | In distribution |
| Z28MAC35SH | Length 100.0 cm | In distribution |
| Z27AL10 | Length 100.0 cm | In distribution |
| Z265CMLC25 | Length 100.0 cm | In distribution |
| Z26ECR35 | Length 100.0 cm | In distribution |
| ZM5FL30 | Length 100.0 cm | In distribution |
| Z27JR35SH | Length 100.0 cm | In distribution |
| Z28JCR40 | Length 100.0 cm | In distribution |
| Z28EBU45 | Catheter Gauge 8.0 Fr | In distribution |
| Z26ARAN9015SH | Catheter Gauge 6.0 Fr | In distribution |
| Z27SAL20 | Curve SAL2.0 | In distribution |
| Z27JR45 | Catheter Gauge 7.0 Fr | In distribution |
| Z26JR30 | Curve JR3.0 | In distribution |
| Z26MAC375 | Length 100.0 cm | In distribution |
| Z26RCBSH | Curve RCB SH | In distribution |
| Z27AR10D | Length 90.0 cm | In distribution |
| Z28JL60SH | Length 100.0 cm | In distribution |
| Z27JR40 | Catheter Gauge 7.0 Fr | In distribution |
| Z27EBU375 | Catheter Gauge 7.0 Fr | In distribution |
| Z26SAR20 | Length 100.0 cm | In distribution |
| Z28JR35 | Length 100.0 cm | In distribution |
| Z26FL30 | Length 100.0 cm | In distribution |
| Z26EBU40SH | Curve EBU4.0 SH | In distribution |
| Z27CHAMP10SH | Length 100.0 cm | In distribution |
| Z26JL405 | Length 100.0 cm | In distribution |
| Z27FL35 | Catheter Gauge 7.0 Fr | In distribution |
| Z26JL40D | Curve JL4.0 | In distribution |
| Z27CHAMP35 | Curve CHAMP3.5 | In distribution |
| Z28JR50 | Catheter Gauge 8.0 Fr | In distribution |
| Z28HSID | Curve HSI | In distribution |
| Z27HSIII | Length 100.0 cm | In distribution |
| Z27FL50SH | Curve FL5.0 SH | In distribution |
| Z26FL35 | Curve FL3.5 | In distribution |
| Z26RBU40SH | Curve RBU4.0 SH | In distribution |
| Z27FR35SH | Curve FR3.5 SH | In distribution |
| Z26FL50 | Length 100.0 cm | In distribution |
| Z28EBU50 | Curve EBU5.0 | In distribution |
| Z26SL35SH | Catheter Gauge 6.0 Fr | In distribution |
| Z28JR50SH | Catheter Gauge 8.0 Fr | In distribution |
| Z26AL25SH | Catheter Gauge 6.0 Fr | In distribution |
| Z28MP1 | Curve MP1 | In distribution |
| Z26AL15SH | Length 100.0 cm | In distribution |
| Z26JR50 | Catheter Gauge 6.0 Fr | In distribution |
| Z28SAL10 | Catheter Gauge 8.0 Fr | In distribution |
| Z28IMASH | Curve IMA SH | In distribution |
| Z26SCR50SH | Curve SCR5.0 SH | In distribution |
| Z26CHAMP40 | Curve CHAMP4.0 | In distribution |
| Z27MB1SH | Length 100.0 cm | In distribution |
| Z26SAL15 | Curve SAL1.5 | In distribution |
| ZM5NOTO | Catheter Gauge 5.0 Fr | In distribution |
| Z26MP1 | Curve MP1 | In distribution |
| Z26MP1A | Length 110.0 cm | In distribution |
| Z27CHAMP30 | Curve CHAMP3.0 | In distribution |
| Z27SAL15 | Curve SAL1.5 | In distribution |
| ZM5JR40 | Curve JR4.0 | In distribution |
| Z27EBU35SH | Length 100.0 cm | In distribution |
| Z26SCR40SH | Length 100.0 cm | In distribution |
| Z28SR40SH | Curve SR4.0 SH | In distribution |
| Z26EBU35 | Curve EBU3.5 | In distribution |
| ZM5MAC40 | Curve MAC4.0 | In distribution |
| Z26SL45SH | Length 100.0 cm | In distribution |
| Z28JL45 | Catheter Gauge 8.0 Fr | In distribution |
| ZM5FR60 | Curve FR6.0 | In distribution |
| Z27EBU30 | Catheter Gauge 7.0 Fr | In distribution |
| Z27EBU50 | Catheter Gauge 7.0 Fr | In distribution |
| Z26SAL10SH | Length 100.0 cm | In distribution |
| Z28JL40A | Catheter Gauge 8.0 Fr | In distribution |
| Z27AL75SH | Catheter Gauge 7.0 Fr | In distribution |
| Z26JCR50 | Curve JCR5.0 | In distribution |
| Z27MP1A | Catheter Gauge 7.0 Fr | In distribution |
| Z26EBU355 | Length 100.0 cm | In distribution |
| Z28JL40SHD | Curve JL4.0 SH | In distribution |
| Z27MAC35SH | Length 100.0 cm | In distribution |
| Z28JR40SH | Length 100.0 cm | In distribution |
| Z26MAC35SH | Curve MAC3.5 SH | In distribution |
| ZM5EBU30 | Length 100.0 cm | In distribution |
| Z27JCL35 | Length 100.0 cm | In distribution |
| Z27MP1SH | Length 100.0 cm | In distribution |
| Z28LCBD | Catheter Gauge 8.0 Fr | In distribution |
| Z26SL35 | Curve SL3.5 | In distribution |
| Z26JR40D | Catheter Gauge 6.0 Fr | In distribution |
| Z26SR40SH | Catheter Gauge 6.0 Fr | In distribution |
| Z26ELGAMAL | Length 100.0 cm | In distribution |
| Z27FL40 | Catheter Gauge 7.0 Fr | In distribution |
| Z26EBU60 | Length 100.0 cm | In distribution |
| Z28MB2SH | Length 100.0 cm | In distribution |
| Z27AL25SH | Catheter Gauge 7.0 Fr | In distribution |
| Z28MB1SH | Length 100.0 cm | In distribution |
| Z26SR35 | Length 100.0 cm | In distribution |
| Z27AL10SH | Curve AL1.0 SH | In distribution |
| Z263DRIGHTSH | 3-D RIGHT SH | In distribution |
| Z27AL15 | Length 100.0 cm | In distribution |
| Z28FL35 | Curve FL3.5 | In distribution |
| ZM5AL30 | Length 100.0 cm | In distribution |
| Z26RBU40 | Length 100.0 cm | In distribution |
| Z26AL75SH | Length 100.0 cm | In distribution |
| Z26SR50 | Length 100.0 cm | In distribution |
| Z26FR50SH | Curve FR5.0 SH | In distribution |
| Z27AL15SH | Length 100.0 cm | In distribution |
| Z26MB1SH | Catheter Gauge 6.0 Fr | In distribution |
| Z26EBU45 | Length 100.0 cm | In distribution |
| Z27FR60SH | Length 100.0 cm | In distribution |
| Z26FL60SH | Catheter Gauge 6.0 Fr | In distribution |
| Z26FR35SH | Curve FR3.5 SH | In distribution |
| Z28SR40 | Length 100.0 cm | In distribution |
| Z27SAL75SH | Catheter Gauge 7.0 Fr | In distribution |
| Z26SAL20 | Length 100.0 cm | In distribution |
| Z28JR40D | Catheter Gauge 8.0 Fr | In distribution |
| Z28HSIII | Curve HSIII | In distribution |
| Z28EBU35D | Length 90.0 cm | In distribution |
| Z28AR10SH | Curve AR1.0 SH | In distribution |
| Z28AR20 | Catheter Gauge 8.0 Fr | In distribution |
| ZM5JR35 | Catheter Gauge 5.0 Fr | In distribution |
| Z26AR10D | Length 90.0 cm | In distribution |
| Z27SL60 | Curve SL6.0 | In distribution |
| Z27SR45 | Curve SR4.5 | In distribution |
| Z28HSIISH | Curve HSII SH | In distribution |
| Z26AR20SH | Length 100.0 cm | In distribution |
| Z28MB2 | Curve MB2 | In distribution |
| Z27MB1 | Catheter Gauge 7.0 Fr | In distribution |
| Z26MAC35 | Length 100.0 cm | In distribution |
| Z28JR45SH | Curve JR4.5 SH | In distribution |
| ZM5AL75 | Catheter Gauge 5.0 Fr | In distribution |
| Z27JR30 | Catheter Gauge 7.0 Fr | In distribution |
| Z28HSISH | Curve HSI SH | In distribution |
| Z28JR40A | Catheter Gauge 8.0 Fr | In distribution |
| Z26CHAMP25 | Catheter Gauge 6.0 Fr | In distribution |
| Z27RB40 | Length 100.0 cm | In distribution |
| Z26CHAMP30 | Curve CHAMP3.0 | In distribution |
| Z26FL40G | Catheter Gauge 6.0 Fr | In distribution |
| Z26SAL20SH | Catheter Gauge 6.0 Fr | In distribution |
| Z27FL40P | Curve FL4.0P | In distribution |
| Z28FL40 | Curve FL4.0 | In distribution |
| Z26SR30 | Catheter Gauge 6.0 Fr | In distribution |
| Z27SAR10 | Curve SAR1.0 | In distribution |
| Z27FR35D | Length 90.0 cm | In distribution |
| Z28JR60SH | Catheter Gauge 8.0 Fr | In distribution |
| Z27EBU40SH | Length 100.0 cm | In distribution |
| Z27COLLIND | Length 90.0 cm | In distribution |
| Z28JL40SH | Length 100.0 cm | In distribution |
| Z28HSIID | Catheter Gauge 8.0 Fr | In distribution |
| Z27FL30SH | Catheter Gauge 7.0 Fr | In distribution |
| Z27JCL30 | Curve JCL3.0 | In distribution |
| ZM5JL35 | Curve JL3.5 | In distribution |
| Z27AL20SH | Curve AL2.0 SH | In distribution |
| Z27SR35SH | Length 100.0 cm | In distribution |
| Z27EBU30SH | Catheter Gauge 7.0 Fr | In distribution |
| Z27FL40G | Length 100.0 cm | In distribution |
| ZM5FR35 | Curve FR3.5 | In distribution |
| Z26AL40 | Catheter Gauge 6.0 Fr | In distribution |
| Z26LCBD | Catheter Gauge 6.0 Fr | In distribution |
| Z28FR40D | Catheter Gauge 8.0 Fr | In distribution |
| Z27IMASHD | Curve IMA SH | In distribution |
| Z28SR35 | Curve SR3.5 | In distribution |
| Z27MAC40 | Length 100.0 cm | In distribution |
| Z27JL35SH | Length 100.0 cm | In distribution |
| Z26MAC40 | Length 100.0 cm | In distribution |
| Z27JR50 | Curve JR5.0 | In distribution |
| Z26CHAMP05 | Length 100.0 cm | In distribution |
| Z26PK1J | Curve PK1 | In distribution |
| Z28JL30 | Catheter Gauge 8.0 Fr | In distribution |
| Z27JL60 | Catheter Gauge 7.0 Fr | In distribution |
| Z28JL30SH | Catheter Gauge 8.0 Fr | In distribution |
| Z26JL30 | Catheter Gauge 6.0 Fr | In distribution |
| ZM5HSI | Length 100.0 cm | In distribution |
| Z27FL40SH | Curve FL4.0 SH | In distribution |
| Z27RCB | Length 100.0 cm | In distribution |
| Z26FR30 | Curve FR3.0 | In distribution |
| Z28FL45 | Length 100.0 cm | In distribution |
| Z27MB2SH | Length 100.0 cm | In distribution |
| Z27ALR12SH | Catheter Gauge 7.0 Fr | In distribution |
| Z28EBU50SH | Length 100.0 cm | In distribution |
| Z26FL45SH | Catheter Gauge 6.0 Fr | In distribution |
| Z26SL50SH | Catheter Gauge 6.0 Fr | In distribution |
| Z28MAC30 | Curve MAC3.0 | In distribution |
| Z26MB1D | Catheter Gauge 6.0 Fr | In distribution |
| Z26AL30 | Length 100.0 cm | In distribution |
| Z27AL20 | Catheter Gauge 7.0 Fr | In distribution |
| Z27AR20SH | Curve AR2.0 SH | In distribution |
| Z26CHAMP15 | Length 100.0 cm | In distribution |
| Z28ECR40 | Length 100.0 cm | In distribution |
| ZM5FL45 | Catheter Gauge 5.0 Fr | In distribution |
| Z27JL40SH | Curve JL4.0 SH | In distribution |
| Z28FR45 | Catheter Gauge 8.0 Fr | In distribution |
| Z28JL40 | Catheter Gauge 8.0 Fr | In distribution |
| Z27FR50SH | Curve FR5.0 SH | In distribution |
| Z26AL10 | Catheter Gauge 6.0 Fr | In distribution |
| Z26JL45 | Length 100.0 cm | In distribution |
| Z27HSIIISH | Catheter Gauge 7.0 Fr | In distribution |
| Z26JL35 | Catheter Gauge 6.0 Fr | In distribution |
| Z26EBU40 | Length 100.0 cm | In distribution |
| Z26SAL75 | Curve SAL.75 | In distribution |
| Z28JL50 | Catheter Gauge 8.0 Fr | In distribution |
| ZM5JR45 | Catheter Gauge 5.0 Fr | In distribution |
| Z27SL45 | Catheter Gauge 7.0 Fr | In distribution |
| Z28ECR40F | Catheter Gauge 8.0 Fr | In distribution |
| Z28MB1 | Curve MB1 | In distribution |
| Z26CHAMP05SH | Length 100.0 cm | In distribution |
| Z26EBU375A | Catheter Gauge 6.0 Fr | In distribution |
| Z27CHAMP20 | Catheter Gauge 7.0 Fr | In distribution |
| Z26HSII | Catheter Gauge 6.0 Fr | In distribution |
| Z28EBU40 | Catheter Gauge 8.0 Fr | In distribution |
| Z27FR35 | Length 100.0 cm | In distribution |
| Z26ECR40 | Curve ECR4.0 | In distribution |
| Z28AL20 | Length 100.0 cm | In distribution |
| Z27IMA | Curve IMA | In distribution |
| Z27AR10SH | Curve AR1.0 SH | In distribution |
| Z27SR50 | Length 100.0 cm | In distribution |
| Z26FR50 | Curve FR5.0 | In distribution |
| Z27JR45SH | Catheter Gauge 7.0 Fr | In distribution |
| Z26JL45SH | Length 100.0 cm | In distribution |
| Z26FR30SH | Length 100.0 cm | In distribution |
| Z27JCL45 | Curve JCL4.5 | In distribution |
| Z26MAC375SH | Curve MAC3.75 SH | In distribution |
| Z26JR50SH | Catheter Gauge 6.0 Fr | In distribution |
| Z28IMASHD | Curve IMA SH | In distribution |
| Z27AL40SH | Curve AL4.0 SH | In distribution |
| Z27JL45 | Length 100.0 cm | In distribution |
| Z26JR40 | Length 100.0 cm | In distribution |
| Z27EBU50 | Curve EBU5.0 | In distribution |
| ZM5SL40 | Curve SL4.0 | In distribution |
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 |
| 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
64 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 | 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 | 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 | 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 | 48 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 | 60 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 | 41 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 | 115 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 | 49 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 | 24 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 | 208 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 | 97 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 | 645 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 | 235 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 | 81 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 | 25 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 | 4 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 | 5 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 | 32 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 | 57 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 | 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 | 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 | 112 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 | 50 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 | 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 |
Showing 40 of 64.
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.