Maquet recalls Fusion Bioline Vascular Grafts from specific lot numbers due to potential reduced blood flow or bleeding risks. Affected units may cause pseudo-aneurysms if used improperly.
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.
Maquet is recalling Fusion Bioline Vascular Grafts from lot 25162546 because one graft from this lot was mixed with another lot and could cause reduced blood flow, bleeding, or pseudo-aneurysms. This recall affects medical devices used in vascular procedures.
The recalled grafts were found to have failed straightness testing, meaning they could be misshapen. This misshapen graft might not fit properly during surgery, leading to reduced blood flow, bleeding, or the formation of a pseudo-aneurysm.
Medical professionals who use Fusion Bioline Vascular Grafts for vascular procedures are most at risk. Patients receiving these grafts from the affected lot numbers could experience complications.
Check the lot number on the graft packaging. Affected units have lot number 25162546. The product is part number M00201503046B0.
Look for lot number 25162546 on the graft packaging.
One graft from lot 25162546 failed straightness testing and was mixed with lot 25162549, which could cause reduced blood flow, bleeding, or pseudo-aneurysms.
The recall record does not specify a remedy, so contact Maquet directly for guidance.
Yes, use of the affected graft could result in reduced blood flow, bleeding, or pseudo-aneurysm formation.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1245-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1245-2023 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
