FDA Device recall Z-1282-2022
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen
- FDA Device
- Class II
- terminated
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class II recall of INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen by Maquet Cardiovascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1282-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-29 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
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
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
Identifiers
| code_info | UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2022%22
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