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Maquet Cardiovascular, LLC recalls INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surfa
Recalled June 29, 2022 · FDA recall Z-1282-2022 · Maquet Cardiovascular
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 · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of SC.
Description
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
Product
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 cardioroot configurations designed for use on the thoracic aorta
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →