The Covera Vascular Covered Stent is a flexible — Class II medical device recall Z-1108-2023
Ongoing recall by Bard Peripheral Vascular Inc, reported 2023-02-15, distributed nationwide. An increase in the reported complaint rate for inability to deploy was identified and related to poor slide bl
| Recall number | Z-1108-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-09 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 10,815 devices |
| UPC / GTIN / UDI-DI | 00801741106170, 00801741106187, 00801741106194, 00801741106200, 00801741106217, 00801741106224, 00801741106231, 00801741106248, 00801741106255, 00801741106262, 00801741106279, 00801741106286, 00801741106293, 00801741106309, 00801741106316, 00801741106323, 00801741106330, 00801741106347, 00801741106354, 00801741106361, 00801741106378, 00801741106385, 00801741106392, 00801741106408, 00801741106415 and 38 more |
| Lot numbers | AVFM06040 |
Product
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
Reason for recall
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
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-1108-2023. 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.