La Ciotat Cedex, France
INTERVASCULAR, SAS recalls
1 recall recorded since 2018, most recently on 12 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 August 2026
- Reason
- Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
- 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, Luxemb
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3258-2026
- Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.