Maquet recalls Hemashield Gold Knitted Bifurcated Vascular Grafts (18mm x 9mm) due to probable mislabeling with Platinum models. Affected units may contain incorrect product specifications.
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
“Maquet Hemashield Gold Knitted Bifurcated Vascular Graft Recall: Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61482-maquet-hemashield-gold-knitted-bifurcated-vascular-graft-recall-mislabeling-risk. Based on FDA recall #Z-0403-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0403-2022%22&limit=1).
The FDA announced on Dec. 1, 2021, that Maquet Cardiovascular, LLC is recalling Hemashield Gold Knitted Bifurcated vascular grafts due to probable mislabeling. The agency said the recall involves two units distributed in Illinois and North Carolina.
How to tell if you have it
Brand: Maquet
Product: Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm
Reference Number: M002020851890
UPC: 00384401017752
Lot Number: 20C04
Serial Numbers: 1260004700 and 1259882880
The hazard
The FDA said there is a probable mislabeling of the product. A Hemashield Platinum Woven Double Velour Bifurcated Vascular Graft may be packaged inside the carton instead of the intended Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Other recent recalls include the Maquet Vasoview Hemopro 2 Gamma Sterilization Issue (June 2, 2026), the Maquet Heartstring III Proximal Seal System Recall (Aug. 15, 2025), and the Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Recall (Aug. 6, 2025). Other recent recalls of similar products include the LeMait Artegraft Vascular Graft Recall Due to Labeling Mix-Up (Feb. 10, 2026), the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026), and the Tornier Perip Screw Recall (Dec. 19, 2025).
How to tell if you have this one
Check for the product name 'Hemashield Gold Knitted Bifurcated Vascular Graft' with size 18 mm x 9 mm. Look for reference number M002020851890 and serial numbers 1260004700 or 1259882880.
Brand
Maquet
Product
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, size (18 mm x 9 mm), reference number M002020851890, and serial numbers 1260004700 or 1259882880.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IL and NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, North Carolina.
Recall timeline
FDA terminated this recall 2.2 years 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-0403-2022 (December 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0403-2022 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.