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 Hemash:shield Platinum Vascular Grafts that may have small holes at seam lines, which could cause bleeding during surgery. This is serious because it risks intra-operative bleeding if the graft is used in a surgical procedure.
The grafts may develop small holes at the seam lines during surgery, which can lead to bleeding at the graft's branch connections. This is a critical issue because it could cause significant blood loss during the procedure.
Surgical teams using the Hemashield Platinum Vascular Grafts for arterial repair are affected. Patients undergoing surgery with these grafts are at risk of bleeding.
Check for the product code M00202175922P0 on the graft. Affected units have serial numbers 1133295245 or 1143826089.
Immediately stop using the Hemashield Platinum Vascular Grafts with the specified serial numbers or product code.
The product code is M00202175922P0.
The affected serial numbers are 1133295245 and 1143826089.
The recall is due to potential small holes at the seam lines of the grafts that could cause intra-operative bleeding.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1878-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1878-2020 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.
