Recall Z-1245-2023— Maquet Cardiovascular, LLC

Name: FDA recall Z-1245-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-30

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-01-30. It names one FDA 510(k) clearance: K131778. Product: Fusion Bioline Vascular Graft, Part number M00201503046B0. 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..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-01-30
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K131778 — FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFTMaquet Cardiovascular, LLC·cleared 2013-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fusion Bioline Vascular Graft, Part number M00201503046B0

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.