Class II — INTERVASCULAR, SAS
| Recalling firm | INTERVASCULAR, SAS |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). |
| Product | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; |
| Quantity | 16329 (3880 US, 12449 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jordan, Kenya, Kosovo, Kuwait, Latvia, Luxembourg, Malaysia, Mauritius, Monaco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Polan… |
| Initiated | 2026-08-12 |
| Classified | 2026-09-23 |
| Recall number | Z-3258-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — INTERVASCULAR, SAS (Z-3258-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99745/
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