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Maquet Cardiovascular, LLC Recall 90272

Description: 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

Maquet Cardiovascular, LLC Recall 90272 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1282-2022
Event ID90272
Event DescriptionINTERGARD 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
Product TypeDevices
DistributionUS Nationwide distribution in the state of SC.
Quantity1 unit
Recall ReasonMislabeled: 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
Device Classification20220629
Device Code InfoUDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656
Center Classification Date20220623
Recall Initiation Date20220429
Recalling FirmMaquet Cardiovascular, LLC
Initial Notification Letter
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