FDA Device recall Z-1245-2023
Fusion Bioline Vascular Graft, Part number M00201503046B0
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Fusion Bioline Vascular Graft, Part number M00201503046B0 by Maquet Cardiovascular, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-30 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Fusion Bioline Vascular Graft, Part number M00201503046B0
Reason
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.
Identifiers
| code_info | UDI-DI 00384409005942 Lot 25162546 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2023%22
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