Maquet recalls Fusion Bioline Vascular Grafts from specific lot numbers due to potential reduced blood flow or bleeding risks. Affected units may cause pseudo-aneurysms if used improperly.
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
“Maquet Fusion Bioline Vascular Graft Recall: Risk of Reduced Blood Flow.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58996-maquet-fusion-bioline-vascular-graft-recall-risk-of-reduced-blood. Based on FDA recall #Z-1245-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2023%22&limit=1).
The FDA announced on Jan. 30, 2023, that Maquet Cardiovascular, LLC is recalling one Fusion Bioline Vascular Graft due to a hazard involving reduced blood flow or bleeding. The agency issued recall number Z-1245-2023 for the Class II voluntary recall.
How to tell if you have it
Brand: Maquet
Product: Fusion Bioline Vascular Graft
Part number: M00201503046B0
UDI-DI: 00384409005942
Lot code: 25162546
Quantity: 1 unit in the US
The hazard
The FDA stated that one graft from lot 25162546 failed guideline straightness testing and was intermingled with lot 25162549. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has had 25 other recalls since Jan. 24, 2019. Recent brand recalls include a June 2, 2026 recall for Vasoview Hemopro 2 devices due to sterilization issues and an Aug. 15, 2025 recall for Heartstring III Proximal Seal Systems regarding hemostasis failure risks. Other recent recalls of similar products include a Feb. 10, 2026 LeMait Artegraft Vascular Graft recall due to labeling mix-ups and an Aug. 12, 2026 Intervascular Cardioroot vascular graft recall for failing water permeability tests.
How to tell if you have this one
Check the lot number on the graft packaging. Affected units have lot number 25162546. The product is part number M00201503046B0.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Graft Lot Number
Look for lot number 25162546 on the graft packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Indiana, Louisiana, Michigan, Missouri, Nevada, New York, North Carolina, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1245-2023 (January 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1245-2023 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.