FDA-Device2026-09-30Class IIPROCESSING DEFECT
Intervascular Cardioroot Woven Collagen Coated Vascular Graft recalled for water permeability defect
What this means
Intervascular's Cardioroot Woven Collagen Coated Vascular Graft failed to meet water permeability specifications in certain batches. The graft is a surgical implant used in vascular procedures. Approximately 16,329 units distributed worldwide are affected.
- Check if your facility has inventory of Cardioroot Woven grafts (Model Numbers HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034).
- Do not use affected grafts in new procedures.
- Contact Intervascular for guidance on existing implants and replacement options.
- Report any complications to your physician or Intervascular immediately.
The agency's original wording
Hazard
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
16329 (3880 US, 12449 OUS)
Manufactured in
1 Zone Industrielle Athelia, La Ciotat Cedex, France
Products
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3258-2026Want us to check the next one for you?
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