EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System — Class II medical device recall Z-1644-2022
Ongoing recall by Medtronic Inc., reported 2022-09-07. Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to parti
| Recall number | Z-1644-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Plymouth, MN, United States |
| Recall initiated | 2022-07-14 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Quantity | 183,964 devices |
| UPC / GTIN / UDI-DI | 00763000051655, 00763000051662, 00763000051679, 00763000051686, 00763000051693, 00763000051709, 00763000051716, 00763000051723, 00763000051730, 00763000051747, 00763000051754, 00763000051761, 00763000051778, 00763000051785, 00763000051792, 00763000051808, 00763000051815, 00763000051822, 00763000051839, 00763000051846, 00763000051853, 00763000051860, 00763000051877, 00763000051884, 00763000051891 and 133 more |
| Model numbers | EVD35-06-020-150, EVD35-07-040-080, EVD35-07-150-080, EVR35-05-020-080, EVR35-05-020-120, EVR35-05-040-080, EVR35-05-040-120, EVR35-05-040-150, EVR35-05-060-080, EVR35-05-060-120, EVR35-05-060-150, EVR35-05-080-080, EVR35-05-080-120, EVR35-05-100-080, EVR35-05-100-120, EVR35-05-120-080, EVR35-05-120-120, EVR35-05-120-150, EVR35-05-150-080, EVR35-05-150-120, EVR35-05-150-150, EVR35-06-020-080, EVR35-06-020-120, EVR35-06-040-080, EVR35-06-040-120 and 133 more |
Product
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Reason for recall
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1644-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.