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FDA · Medical devices ·

Cardioroot Woven Collagen Coated Vascular Graft recall

INTERVASCULAR, SAS recalled Cardioroot Woven Collagen Coated Vascular Graft on September 30, 2026 because of product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). It was sold nationwide.

Why it was recalled

Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

What's recalled

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;

Quantity: 16329 (3880 US, 12449 OUS)

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
INTERVASCULAR, SAS, La Ciotat Cedex
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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, Luxem…
Status
Ongoing
Recall number
Z-3258-2026
Source
U.S. Food and Drug Administration

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