FDAJanuary 30, 2023device
Fusion Bioline Vascular Graft, Part number M00201503046B0
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
maquet cardiovascularmaquet
UPCs
00384409005942
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;2026-01-09
- FDAHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
- FDAVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting T...2025-08-06
- FDACorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
- FDASprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.2025-06-27
- FDAServo-n Ventilator System. Model Number: 6694800.2025-05-30
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