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Maquet Cardiovascular, LLC recalls Fusion Bioline Vascular Graft, Part number M00201503046B0
Recalled March 22, 2023 · FDA recall Z-1245-2023 · Maquet Cardiovascular
Hazard
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. · FDA Class II
Units
1 (US)
Sold at
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Description
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.
Product
Fusion Bioline Vascular Graft, Part number M00201503046B0
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →