Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1282-2022 — 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

U.S. FDA — Device Enforcement · United States · 2022-04-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1282-2022
Date of alert: 2022-04-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Maquet Cardiovascular, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00384401000280

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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