Maquet recalls HEMASHIELD Gold vascular grafts with mismatched labeling that could disrupt blood vessel repairs, risking pseudo-aneurysms. Affected units have specific size and lot numbers.
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Maquet is recalling HEMASHIELD Gold knitted vascular grafts that have mismatched labeling between the outer packaging and inner sterile packaging. This mismatch could cause long-term blood vessel problems like pseudo-aneurysms if the graft is used incorrectly.
The product's outer labeling describes a bifurcated graft (16x8mm, 40cm) but the inner sterile packaging labels it as a straight graft (7mm, 60cm). This mismatch could cause blood vessels to leak or form abnormal bulges over time.
Healthcare professionals using the grafts for vascular repairs are most at risk. Patients receiving the grafts during surgery may also be affected if the wrong size is used.
Check for product code M002020952070, lot number 21B10, or serial number 1318567653 on the packaging. The grafts are 7mm diameter and 60cm length, intended for artery repairs.
Compare the outer packaging label with the inner sterile packaging label to ensure they match the product specifications.
The recalled grafts are 7mm in diameter and 60cm in length.
The recall states that mislabeled product could disrupt vascular anastomosis, potentially creating a pseudo-aneurysm, but the remedy does not specify immediate danger.
Check for product code M002020952070, lot number 21B10, or serial number 1318567653 on the packaging.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0729-2022 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0729-2022 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.
