Maquet recalls Hemashield Platinum Woven Double Velour Vascular Grafts with 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 surgery.
The grafts may develop small holes at the seam lines during surgical procedures. This can lead to bleeding at the graft's connection points, potentially causing serious complications during surgery.
Surgical teams using the Hemashield Platinum Vascular Grafts for arterial repair or replacement are affected. Patients undergoing vascular surgery with these grafts are at risk of bleeding.
Check for the product code M00202175820P0 on the graft. Affected units have specific serial numbers: 1120090850, 1120109758, 1120080956, 1120074392, 1120099148, 1137597566, 1137603753, 1183458035.
Discontinue use of the Hemashield Platinum Vascular Grafts with the listed serial numbers as they pose a risk of intra-operative bleeding.
The product code is M00202175820P0.
Affected serial numbers are 1120090850, 1120109758, 1120080956, 1120074392, 1120099148, 1137597566, 1137603753, and 1183458035.
The grafts may have small holes at the seam lines, which can cause bleeding during surgery.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1868-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1868-2020 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.
