FDAApril 29, 2022device
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioro...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascularmaquet
UPCs
00384401000280
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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