Maquet recalls Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines causing intra-operative bleeding. Affected units have specific serial numbers.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Maquet is recalling Hemashield Platinum Vascular Grafts that may have small holes at seam lines, which could cause bleeding during surgery. This is a serious risk for patients undergoing vascular repair procedures.
The grafts may develop small holes at the seam lines during surgical use, leading to bleeding at the graft connections. This could cause significant blood loss during the procedure if the holes are not detected.
Healthcare professionals using the Hemashield Platinum Vascular Grafts for arterial repair procedures are affected. Patients undergoing surgery with these grafts are at risk of bleeding.
Check for the product code M00202175730AP0 and serial numbers 1124104830 or 1165164445. These grafts are used for arterial repair in patients with aneurysms or occlusive disease.
Immediately discontinue use of the Hemashield Platinum Vascular Grafts with the specified serial numbers and product code.
The recall is due to potential small holes at the seam lines of the grafts that could cause intra-operative bleeding during surgical procedures.
The affected serial numbers are 1124104830 and 1165164445.
Check for the product code M00202175730AP0 and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1865-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1865-2020 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.