Cardioroot Woven Collagen Coated Vascular Graft
The Cardioroot Woven Collagen Coated Vascular Graft failed water permeability acceptance criteria.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
INTERVASCULAR, SAS, of La Ciotat Cedex, France, recalled the Cardioroot Woven Collagen Coated Vascular Graft because the product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). The recall began August 12, 2026, and was added to the FDA's Enforcement Report on September 23, 2026. The graft was distributed worldwide, including US Nationwide and numerous countries.
The recall affects the graft models HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, and HEWROOT0034. The company initiated the recall due to the permeability issue.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
Cardioroot Woven Collagen Coated Vascular Graft
- Model
- HEWROOT0024
- HEWROOT0026
- HEWROOT0028
- HEWROOT0030
- HEWROOT0032
- HEWROOT0034
- UDI-DI
- 00384401013884
- 00384401013891
- 00384401013907
- 00384401013914
- 00384401013921
- 00384401013938
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99745
- Recall No.
- Z-3258-2026
- Company
- INTERVASCULAR, SASLa Ciotat Cedex, France
- Hazard
- Device defect
- Quantity recalled
- 16329 (3880 US, 12449 OUS)
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
