Intervascular, Sas recall: Cardioroot Woven Collagen Coated Vascular Graft
Intervascular, Sas is recalling Cardioroot Woven Collagen Coated Vascular Graft – 16329 (3880 US, 12449 OUS). The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 12, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Cardioroot Woven Collagen Coated Vascular Graft |
| Brand | Intervascular, Sas |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 12, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 16329 (3880 US, 12449 OUS) |
| Recall ID | 99745 |
Recalled products
- Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
- FDA recall number
- Z-3258-2026
- Codes, lots and dates
- 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;
- Quantity
- 16329 (3880 US, 12449 OUS)
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99745
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- La Ciotat Cedex, France
Why it was recalled
The reason the FDA lists: “Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99745, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Intervascular, Sas Cardioroot Woven Collagen Coated Vascular Graft recalled?
Yes. Intervascular, Sas recalled it on August 12, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.