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.
Other recalls by Maquet Cardiovascular
- The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
FDA Device · Class II · 2026-07-22 · Maquet Cardiovascular - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000
FDA Device · Class II · 2025-10-01 · Maquet Cardiovascular - Heartstring III Proximal Seal System
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular
All Maquet Cardiovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.