FLAIR Endovascular Stent Graft — Class II medical device recall Z-0223-2016
Terminated recall by Bard Peripheral Vascular Inc, reported 2015-11-11, distributed nationwide. Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associ
| Recall number | Z-0223-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2015-10-19 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 292 units |
| Lot numbers | ANWJ3097, ANWJ3098, ANWJ3099, ANWJ3216, ANWJ3217, ANWK0056, ANWK0057, ANWK0058, ANWK0567, ANWK0568, ANWK0569, ANWK0570, ANWK0571, ANWK0572, ANWK0580, ANWK0581, ANWK0582, ANWK0583, ANWK1097, ANWK1098, ANWK1099, ANWK1100, ANWK1101, ANWK2441, ANWK2442, ANWK2443, ANWK2444, ANWK2445, ANWK2446, ANWK2447, ANWK3391, ANWK3392, ANWK3393, ANWK3394, ANWK3570, ANWK3571, ANWK3572, ANWK3809, ANWK3810, ANWK3811 and 252 more |
Product
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.
Reason for recall
Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.
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-0223-2016. 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.