Recall Z-3258-2026— INTERVASCULAR, SAS

Name: FDA recall Z-3258-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Class II · Ongoing

Class II FDA medical device recall by INTERVASCULAR, SAS, initiated 2026-08-12. It names one FDA 510(k) clearance: K103347. Product: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;. Reason: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP)..

Recalling firm: INTERVASCULAR, SAS
Classification: Class II
Status: Ongoing
Initiated: 2026-08-12
Firm location: La Ciotat Cedex, France

510(k) clearances named in this recall

1 on FDA's record

K103347 — CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESESIntervascular Sas·cleared 2011-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.