Fusion Bioline Vascular Graft — Class II medical device recall Z-1245-2023
Ongoing recall by Maquet Cardiovascular, LLC, reported 2023-03-22, distributed nationwide. One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was inte
| Recall number | Z-1245-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-03-10 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00384409005942 |
| Lot numbers | 25162546 |
| Model numbers | M00201503046B0 |
Product
Fusion Bioline Vascular Graft, Part number M00201503046B0
Reason for recall
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
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-1245-2023. 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.