INTERGARD Woven Vascular Graft is a woven polyester graft coated with… — Class II medical device recall Z-1282-2022
Terminated recall by Maquet Cardiovascular, LLC, reported 2022-06-29, distributed nationwide. Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an
| Recall number | Z-1282-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2022-04-29 |
| Classified | 2022-06-23 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2024-04-18 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00384401000280 |
| Lot numbers | 20L12 |
| Serial numbers | 1303435656 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1282-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.