Launcher™
Catheter LA5EBU20L Launcher 5F 50CM EB20
14manufacturers in China registered for this device type
3,805catalogue 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) | K230156 |
| Record published | 2024-05-12 |
| Record revised | 2024-06-14 (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: Keep away from sunlight |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 5 to 8 Fr; length 45 to 130 cm; catheter length 45 to 130 cm |
| Distribution end date | 2024-12-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LA5MAC35 | Curve description 1: MAC3.5 | In distribution |
| LA6AL15 | Curve AL1.5 | In distribution |
| LA6AL30 | Catheter Gauge 6.0 Fr | In distribution |
| LA6LCB | Length 100.0 cm | In distribution |
| LA7LCBSHD | Curve LCB SH | In distribution |
| LA6ERADRST | Catheter Gauge 6.0 Fr | In distribution |
| LA7JR35SHD | Curve description 1: JR3.5 | In distribution |
| LA6ELGAMALSH | Catheter Length 100.0 cm | In distribution |
| LA6EBU30D | Curve EBU3.0 | In distribution |
| LA6SAL15SH | Curve description 1: SAL1.5 | In distribution |
| LA8AL75F | Catheter Gauge 8.0 Fr | In distribution |
| LA6FL40SH | Curve FL4.0 SH | In distribution |
| LA6IMASH | Curve description 1: IMA | In distribution |
| LA8MAC30SH | Length 100.0 cm | In distribution |
| LA5MAC35 | Curve MAC3.5 | In distribution |
| LA8SAL10 | Curve Description 1: SAL1.0 | In distribution |
| LA7SAL10SHD | Curve descripton 3: 90CM | In distribution |
| LA7AL75SHD | Length 90.0 cm | In distribution |
| LA5JR45 | Curve JR4.5 | In distribution |
| LA5RICAD | Curve RICA | In distribution |
| LA8MP1SH | Length 100.0 cm | In distribution |
| LA6MB1K | Curve description 1: MB1 | In distribution |
| LA5ECR35 | Catheter Gauge 5.0 Fr | In distribution |
| LA6DC45 | Catheter Length 100.0 cm | In distribution |
| LA7JCL35SH | Catheter Gauge 7.0 Fr | In distribution |
| LA8JL50SHD | Length 90.0 cm | In distribution |
| LA6EBU375A | Catheter Gauge 6.0 Fr | In distribution |
| LA8CHAMP20SH | Curve description 2: SH | In distribution |
| LA8AL15SH | Length 100.0 cm | In distribution |
| LA6SL50SH | Catheter Gauge 6.0 Fr | In distribution |
| LA6JL30 | Catheter Gauge 6.0 Fr | In distribution |
| LA8SR40SH | Curve Description 1: SR4.0 | In distribution |
| LA8JR35SH | Length 100.0 cm | In distribution |
| LA6JR35D | Catheter Gauge 6.0 Fr | In distribution |
| LA6FR35 | Catheter Gauge 6.0 Fr | In distribution |
| LA6AL30 | Catheter Length 100.0 cm | In distribution |
| LA6FL40ST | Curve FL4.0 SHORT TIP | In distribution |
| LA6AR20SHD | Catheter Gauge 6.0 Fr | In distribution |
| LA7JCL40D | Length 90.0 cm | In distribution |
| LA8EBU40D | Length 90.0 cm | In distribution |
| LA7ECR40 | Length 100.0 cm | In distribution |
| LA8JL50 | Catheter Gauge 8.0 Fr | In distribution |
| LA7ELGAMALSH | Length 100.0 cm | In distribution |
| LA8JL45SH | Curve JL4.5 SH | In distribution |
| LA5JL50A | Catheter Gauge 5.0 Fr | In distribution |
| LA6ERADRST | Curve ERAD RIGHT SHORT TIP | In distribution |
| LA7SR30SH | Curve SR3.0 SH | In distribution |
| LA7MAC35D | Catheter Gauge 7.0 Fr | In distribution |
| LA6SAL75SH | Catheter Gauge 6.0 Fr | In distribution |
| LA7JR60SH | Length 100.0 cm | In distribution |
| LA6IMAY | Catheter Length 118.0 cm | In distribution |
| LA7MB2 | Catheter Gauge 7.0 Fr | In distribution |
| LA5AL15 | Catheter Gauge 5.0 Fr | In distribution |
| LA6SL40 | Curve SL4.0 | In distribution |
| LA5MAC45 | Curve MAC4.5 | In distribution |
| LA8JR35 | Length 100.0 cm | In distribution |
| LA6SCR50SH | Length 100.0 cm | In distribution |
| LA6IMASHF | Catheter Length 80.0 cm | In distribution |
| LA7SAL75 | Length 100.0 cm | In distribution |
| LA7JL35SH | Length 100.0 cm | In distribution |
| LA6ALR12A | Curve description 2: 110CM | In distribution |
| LA7DC40 | Catheter Gauge 7.0 Fr | In distribution |
| LA7AL25 | Length 100.0 cm | In distribution |
| LA6AR10 | Length 100.0 cm | In distribution |
| LA6EBU30A | Catheter Gauge 6.0 Fr | In distribution |
| LA7JCL40D | Curve description 2: 90CM | In distribution |
| LA6EBU40D | Curve EBU4.0 | In distribution |
| LA6AR20 | Length 100.0 cm | In distribution |
| LA7AL75F | Length 80.0 cm | In distribution |
| LA7CHAMP20SH | Curve CHAMP2.0 SH | In distribution |
| LA8JR40SHD | Catheter Gauge 8.0 Fr | In distribution |
| LA6JR35 | Catheter Length 100.0 cm | In distribution |
| LA8EBU35SH | Curve EBU3.5 SH | In distribution |
| LA8AL10F | Length 80.0 cm | In distribution |
| LA6ERADL | Catheter Gauge 6.0 Fr | In distribution |
| LA7EBU325 | Length 100.0 cm | In distribution |
| LA7SAL15 | Catheter Gauge 7.0 Fr | In distribution |
| LA6JL35A | Curve description 1: JL3.5 | In distribution |
| LA6AL175 | Curve AL1.75 | In distribution |
| LA6EBU35SHD | Curve description 2: SH | In distribution |
| LA63DRCD | Length 90.0 cm | In distribution |
| LA5JCL15 | Length 100.0 cm | In distribution |
| LA8AR10D | Length 90.0 cm | In distribution |
| LA6EBU25 | Catheter Length 100.0 cm | In distribution |
| LA6JR40MOD | Curve JR4.0 MOD | In distribution |
| LA8EBU35SH | Curve EBU3.5 SH | In distribution |
| LA6JR30SH | Curve JR3.0 SH | In distribution |
| LA6JL45 | Catheter Gauge 6.0 Fr | In distribution |
| LA6JCL35SH | Catheter Gauge 6.0 Fr | In distribution |
| LA8AR10 | Curve Description 1: AR1.0 | In distribution |
| LA6EBU35Y | Length 118.0 cm | In distribution |
| LA6JL40MOD | Catheter Gauge 6.0 Fr | In distribution |
| LA5AR20 | Catheter Gauge 5.0 Fr | In distribution |
| LA5SCR40 | Catheter Gauge 5.0 Fr | In distribution |
| LA6SR45 | Length 100.0 cm | In distribution |
| LA63DRCSHD | Catheter Gauge 6.0 Fr | In distribution |
| LA8AL30 | Length 100.0 cm | In distribution |
| LA7MAC50 | Curve description 1: MAC5.0 | In distribution |
| LA6EBU30D | Curve description 1: EBU3.0 | In distribution |
| LA8EBU375 | Length 100.0 cm | In distribution |
| LA6JR60A | Length 110.0 cm | In distribution |
| LA6FL45ST | Catheter Gauge 6.0 Fr | In distribution |
| LA5MAC35 | Catheter Gauge 5.0 Fr | In distribution |
| LA6ECR35 | Curve description 1: ECR3.5 | In distribution |
| LA5MP1K | Curve description 1: MP1 | In distribution |
| LA7MAC40 | Catheter Gauge 7.0 Fr | In distribution |
| LA7EBU375SH | Curve EBU3.75 SH | In distribution |
| LA6PAPA1Y | Catheter Gauge 6.0 Fr | In distribution |
| LA6JR45A | Length 110.0 cm | In distribution |
| LA6AL10A | Curve description 2: 110CM | In distribution |
| LA7SAL75SHD | Curve description 2: SH | In distribution |
| LA8CHAMP40SH | Curve CHAMP4.0 SH | In distribution |
| LA6SAL30 | Catheter Gauge 6.0 Fr | In distribution |
| LA6HSIII | Catheter Gauge 6.0 Fr | In distribution |
| LA6RCB | Length 100.0 cm | In distribution |
| LA8EBU35SHD | Catheter Gauge 8.0 Fr | In distribution |
| LA8AL25 | Catheter Gauge 8.0 Fr | In distribution |
| LA6EBU40F | Curve description 1: EBU4.0 | In distribution |
| LA6JL40 | Catheter Gauge 6.0 Fr | In distribution |
| LA7HSI | Curve HSI | In distribution |
| LA5JR40Y | Length 118.0 cm | In distribution |
| LA6MAC45SH | Length 100.0 cm | In distribution |
| LA6EBU40SHA | Length 110.0 cm | In distribution |
| LA8AL15D | Length 90.0 cm | In distribution |
| LA8SCR35 | Length 100.0 cm | In distribution |
| LA8RCBSHD | Curve RCB SH | In distribution |
| LA8AL10J | Curve AL1.0 | In distribution |
| LA8SAL75SH | Curve SAL.75 SH | In distribution |
| LA7CHAMP25K | Curve description 1: CHAMP2.5 | In distribution |
| LA5MB1XL | Curve description 1: MB1 | In distribution |
| LA6JR45 | Catheter Gauge 6.0 Fr | In distribution |
| LA7JL40A | Length 110.0 cm | In distribution |
| LA8SAL15SH | Curve Description 1: SAL1.5 | In distribution |
| LA6PAPA1 | Length 100.0 cm | In distribution |
| LA8EBU35F | Length 80.0 cm | In distribution |
| LA6JR40K | Catheter Gauge 6.0 Fr | In distribution |
| LA6MRADIAL | Curve description 1: MRADIAL | In distribution |
| LA8SL30 | Catheter Gauge 8.0 Fr | In distribution |
| LA5JR40 | Length 100.0 cm | In distribution |
| LA6JCL40 | Curve JCL4.0 | In distribution |
| LA6ERADLLTSH | Catheter Gauge 6.0 Fr | In distribution |
| LA53DRC | Curve 3DRC | In distribution |
| LA8CHAMP20K | Catheter Gauge 8.0 Fr | In distribution |
| LA7JCL30SH | Catheter Gauge 7.0 Fr | In distribution |
| LA6FL45ST | Catheter Gauge 6.0 Fr | In distribution |
| LA6EBU45D | Length 90.0 cm | In distribution |
| LA7MB1 | Curve description 1: MB1 | In distribution |
| LA5JCL15 | Length 100.0 cm | In distribution |
| LA8EBU40 | Length 100.0 cm | In distribution |
| LA7EBU45 | Curve EBU4.5 | In distribution |
| LA6AL20D | Curve description 1: AL2.0 | In distribution |
| LA6EBU40 | Curve description 1: EBU4.0 | In distribution |
| LA6LCBSHD | Length 90.0 cm | In distribution |
| LA6JL50F | Curve description 1: JL5.0 | In distribution |
| LA5ERADL | Length 100.0 cm | In distribution |
| LA6JL35SH | Length 100.0 cm | In distribution |
| LA5MRADIALY | Catheter Gauge 5.0 Fr | In distribution |
| LA5JCR50 | Length 100.0 cm | In distribution |
| LA6AR20 | Curve description 1: AR2.0 | In distribution |
| LA8VXJR40SH | Curve description 2: SH | In distribution |
| LA7AR10F | Curve AR1.0 | In distribution |
| LA7RCBII | Length 100.0 cm | In distribution |
| LA5MRADIAL | Length 100.0 cm | In distribution |
| LA8VXJR35 | Length 100.0 cm | In distribution |
| LA6JR50SH | Catheter Gauge 6.0 Fr | In distribution |
| LA8CHAMP15SH | Catheter Gauge 8.0 Fr | In distribution |
| LA6SCR35K | Catheter Length 55.0 cm | In distribution |
| LA5AL20A | Length 110.0 cm | In distribution |
| LA6RCBSH | Curve RCB SH | In distribution |
| LA8MP1SHD | Curve Description 1: MP1 | In distribution |
| LA8EBU35SHD | Curve EBU3.5 SH | In distribution |
| LA6AL1045 | Catheter Gauge 6.0 Fr | In distribution |
| LA6ERADRSH | Curve description 2: SH | In distribution |
| LA7JL45SH | Curve description 1: JL4.5 | In distribution |
| LA6EBU30 | Length 100.0 cm | In distribution |
| LA5JCL45 | Curve description 1: JCL4.5 | In distribution |
| LA8RBU40 | Curve Description 1: RBU4.0 | In distribution |
| LA6JCL45 | Catheter Gauge 6.0 Fr | In distribution |
| LA8IMASHD | Length 90.0 cm | In distribution |
| LA8AL30 | Catheter Gauge 8.0 Fr | In distribution |
| LA7SL40 | Length 100.0 cm | In distribution |
| LA5MAC50 | Length 100.0 cm | In distribution |
| LA7RCBSHD | Catheter Gauge 7.0 Fr | In distribution |
| LA8ECR35SH | Length 100.0 cm | In distribution |
| LA6RBU40SH | Curve RBU4.0 SH | In distribution |
| LA8SAL15SHD | Curve description 2: SH | In distribution |
| LA8DC30SH | Catheter Gauge 8.0 Fr | In distribution |
| LA6IMAH | Length 70.0 cm | In distribution |
| LA7HSIISH | Length 100.0 cm | In distribution |
| LA6EBU30A | Catheter Gauge 6.0 Fr | In distribution |
| LA8ELGAMAL | Length 100.0 cm | In distribution |
| LA73DRC | Length 100.0 cm | In distribution |
| LA6HSIII | Length 100.0 cm | In distribution |
| LA6JCLRAD35 | Catheter Gauge 6.0 Fr | In distribution |
| LA6MP2 | Curve description 1: MP2 | In distribution |
| LA6ERADL | Catheter Gauge 6.0 Fr | In distribution |
| LA8HSIII | Catheter Gauge 8.0 Fr | In distribution |
| LA6JR40 | Curve JR4.0 | In distribution |
| LA6ECR35SH | Length 100.0 cm | In distribution |
| LA5JL505 | Curve JL5.0 | In distribution |
| LA7JL45A | Curve JL4.5 | In distribution |
| LA6JCR50 | Length 100.0 cm | In distribution |
| LA6ELGAMAL | Catheter Gauge 6.0 Fr | In distribution |
| LA8RBU35SH | Length 100.0 cm | In distribution |
| LA6CHAMP25SH | Curve description 1: CHAMP2.5 | In distribution |
| LA7HSIV | Length 45.0 cm | In distribution |
| LA8EBU375 | Curve EBU3.75 | In distribution |
| LA7JR40SHD | Catheter Gauge 7.0 Fr | In distribution |
| LA6JR30K | Catheter Length 55.0 cm | In distribution |
| LA6JR40 | Catheter Length 100.0 cm | In distribution |
| LA7RBU40SH | Catheter Gauge 7.0 Fr | In distribution |
| LA8AR10SH | Curve Description 1: AR1.0 | In distribution |
| LA7MRADIAL | Length 100.0 cm | In distribution |
| LA8MAC35D | Catheter Gauge 8.0 Fr | In distribution |
| LA6CHAMP30SH | Curve description 2: SH | In distribution |
| LA7RBU40SH | Catheter Gauge 7.0 Fr | In distribution |
| LA6SCR40 | Curve SCR4.0 | In distribution |
| LA6SL45 | Length 100.0 cm | In distribution |
| LA6JCL40SH | Curve JCL4.0 SH | In distribution |
| LA7ARA7515 | Length 100.0 cm | In distribution |
| LA6SL40SH | Catheter Gauge 6.0 Fr | In distribution |
| LA6RMHSII | Catheter Gauge 6.0 Fr | In distribution |
| LA6SL30 | Catheter Gauge 6.0 Fr | In distribution |
| LA7MB2 | Length 100.0 cm | In distribution |
| LA6AL20SH | Curve AL2.0 SH | In distribution |
| LA6IMAMOD | Catheter Gauge 6.0 Fr | In distribution |
| LA6EBU35 | Catheter Length 100.0 cm | In distribution |
| LA6MAC45 | Catheter Length 100.0 cm | In distribution |
| LA6ELGAMAL | Curve description 1: EL GAMAL | In distribution |
| LA7MAC375 | Length 100.0 cm | In distribution |
| LA6AL20 | Curve description 1: AL2.0 | In distribution |
| LA5AL20A | Curve description 1: AL2.0 | In distribution |
| LA8MP1SH | Length 100.0 cm | In distribution |
| LA8AL20SHD | Curve description 3: 90CM | In distribution |
| LA7MAC40 | Length 100.0 cm | In distribution |
| LA6JR60SH | Catheter Gauge 6.0 Fr | In distribution |
| LA6ECR30 | Length 100.0 cm | In distribution |
| LA7RCB | Catheter Gauge 7.0 Fr | In distribution |
| LA6EBU35SHA | Length 110.0 cm | In distribution |
| LA6JL45SH | Curve JL4.5 SH | In distribution |
| LA8MAC50 | Length 100.0 cm | In distribution |
| LA5JR355 | Catheter Gauge 5.0 Fr | In distribution |
| LA6IMAD | Catheter Gauge 6.0 Fr | In distribution |
| LA6FL50ST | Length 100.0 cm | In distribution |
| LA6PK1W | Curve PK1 | In distribution |
| LA5SCR40 | Length 100.0 cm | In distribution |
| LA6PK1W | Length 47.0 cm | In distribution |
| LA7JL60 | Length 100.0 cm | In distribution |
| LA7IMAD | Length 90.0 cm | In distribution |
| LA6SCR40SH | Catheter Gauge 6.0 Fr | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
65 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 | 2021-01-15 | Class II | Process control | Sterility may be compromised due to an unsealed pouch | 1 unit | 2023-06-15 |
| Medtronic Vascular | 510(k) number | 2021-01-15 | Class II | Process control | Sterility may be compromised due to an unsealed pouch | 9 units | 2023-06-15 |
| Medtronic Vascular | 510(k) number | 2021-01-15 | Class II | Process control | Sterility may be compromised due to an unsealed pouch | 10 Units | 2023-06-15 |
| Medtronic Vascular | 510(k) number | 2021-01-15 | Class II | Process control | Sterility may be compromised due to an unsealed pouch | 137 units | 2023-06-15 |
| Medtronic Vascular | 510(k) number | 2014-10-13 | Class II | Process control | Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 | 11 devices | 2015-02-18 |
| Medtronic, Inc. | 510(k) number | 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 |
| Medtronic Vascular | 510(k) number | 2006-04-05 | Not classified | Other | Potential for non-sterility due to loss of package integrity | 3547 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 | 1514 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 | 33 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 | 47 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 | 29 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 | 52 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 | 114 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 | 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 | 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 | 122 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 | 145 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 | 71 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 | 128 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 | 680 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 | 195 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 | 2204 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 | 38 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 | 543 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 | 107 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 | 65 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 | 69 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 | 71 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 | 416 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 |
Showing 40 of 65.
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 |
| 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.