Recall Z-1644-2022 ยท NIP Stent, Superficial Femoral Artery
Medtronic Inc.
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
| Date | Jul 14, 2022 |
| Status | Open, Classified |
| Reason | Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. |
| Root cause | Other |
| Action | In the United States (US) on 14-Jul-2022, a written Medical Device Correction letter was mailed via 2-day tracked delivery to all consignees who have received affected product according to Medtronic Records. Outside the United States (OUS), beginning on 14-Jul-2022 a written Medical Device Correction letter was delivered to consignees who have received potentially affected product according to Medtronic records via regionally approved methods. For both US and OUS customers the letter notified customers of the correction (IFU update), provided a video link that demonstrates the updated procedur |
| Quantity | 183964 devices |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.