TemporaryFDAOngoing
Can cause harm that is usually temporary.
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
Check the device or its packaging for
1. Model Number: HEWROOT0024; UDI-DI: 00384401013884; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 2. Model Number: HEWROOT0026; UDI-DI: 00384401013891; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 3. Model Number: HEWROOT0028; UDI-DI: 00384401013907; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 4. Model Number: HEWROOT0030; UDI-DI: 00384401013914; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 5. Model Number: HEWROOT0032; UDI-DI: 00384401013921; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 6. Model Number: HEWROOT0034; UDI-DI: 00384401013938; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;
- Why
- Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
- Distributed
- 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, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Yemen.
- Company
- INTERVASCULAR, SAS
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3258-2026 · retrieved 23 September 2026
Read the official notice