Skip to content
Recall Observatory FDA recall evidence

Device product

Fusion Bioline Vascular Graft, Part number M00201503046B0

Z-1245-2023

January 30, 2023

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 91671
Status
Ongoing
Classification
Class II
Quantity
1 (US)
Official record key
device-enforcement:Z-1245-2023

Official wording

Reason: 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.

Code information: UDI-DI 00384409005942 Lot 25162546

Distribution pattern: US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.