Recall Z-3258-2026 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
INTERVASCULAR, SAS
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
| Date | Sep 23, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). |
| Root cause | Under Investigation by firm |
| Action | On August 12, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Ensure all affected product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Always report any adverse events potentially related to the affected products to your Getinge representative. |
| 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, Luxemb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular Sas, Feb 2, 2011 |