Everflex Self-Expanding Peripheral Stent with Entrust Delivery System… — Class II medical device recall Z-0188-2018
Terminated recall by Medtronic Inc., reported 2017-12-06, distributed nationwide. Stent length on the label may not match the length of the stent itself.
| Recall number | Z-0188-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Plymouth, MN, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2017-11-29 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2020-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00821684051436, 00821684051467 |
| Lot numbers | A476301, A476328 |
| Model numbers | EVD35-07-060-120, EVD35-07-120-120 |
Product
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Reason for recall
Stent length on the label may not match the length of the stent itself.
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-0188-2018. 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.