Maquet Cardiovascular, LLC: Medical Device Recall in 2023 - (Recall #: Z-1245-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Fusion Bioline Vascular Graft, Part number M00201503046B0

Product Classification:

Class II

Date Initiated: January 30, 2023

Date Posted: March 22, 2023

Recall Number: Z-1245-2023

Event ID: 91671

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1 (US)

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.

Voluntary or Mandated:

Voluntary: Firm initiated