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 HEMASHIELD Gold Vascular Graft Recall: Mislabeled Product Risks Vascular.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61265-maquet-hemashield-gold-vascular-graft-recall-mislabeled-product-risks-vascular. Based on FDA recall #Z-0729-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0729-2022%22&limit=1).
Maquet Cardiovascular, LLC recalled one HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT due to mislabeling that could cause a pseudo-aneurysm, according to the FDA. The Food and Drug Administration announced the Class II recall on Jan. 14, 2022.
The outer labeling of the HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft does not correspond to the inner sterile packaging labeling. This mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Recent Maquet recalls include a June 2, 2026 announcement regarding gamma sterilization issues with Vasoview Hemopro 2 devices and an Aug. 15, 2025 recall of the Heartstring III Proximal Seal System due to bleeding risks. Other recent recalls of similar products include LeMait's Feb. 10, 2026 Artegraft Vascular Graft Recall Due to Labeling Mix-Up and Intervascular's Aug. 12, 2026 Cardioroot Vascular Grafts May Fail Water Permeability Test.
How to tell if you have this one
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.
Brand
Maquet
Product
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Product Labeling
Compare the outer packaging label with the inner sterile packaging label to ensure they match the product specifications.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0729-2022 (January 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0729-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.