Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4.…
Intervascular, Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INTERVASCULAR, SAS · 1 Zone Industrielle Athelia · La Ciotat Cedex · N/A
Is this the product you have?
- Cardioroot Woven Collagen Coated Vascular Graft
- Model Numbers
1. HEWROOT00242. HEWROOT00263. HEWROOT00284. HEWROOT00305. HEWROOT00326. HEWROOT0034
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published HEWROOT002400384401013884UDI-DI: 00384401013884; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life HEWROOT002600384401013891UDI-DI: 00384401013891; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life HEWROOT002800384401013907UDI-DI: 00384401013907; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life HEWROOT003000384401013914UDI-DI: 00384401013914; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life HEWROOT003200384401013921UDI-DI: 00384401013921; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life HEWROOT003400384401013938UDI-DI: 00384401013938; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life - Amount recalled
- 16329 (3880 US, 12449 OUS)
Where it was sold
- Nationwide
Why it was recalled
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
This product could cause temporary or reversible health problems — stop using it.
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