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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1282-2022 |
| Event ID | 90272 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of SC. |
| Quantity | 1 unit |
| Recall Reason | 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 |
| Device Classification | 20220629 |
| Device Code Info | UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656 |
| Center Classification Date | 20220623 |
| Recall Initiation Date | 20220429 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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