Home / Recalls / INTERVASCULAR, SAS / Z-3258-2026

Z-3258-2026 Class II Ongoing

Recalled by INTERVASCULAR, SAS — La Ciotat Cedex

FDA device recall Z-3258-2026 was initiated by INTERVASCULAR, SAS on Aug 12, 2026 and is designated Class II. Reason for recall: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). The recall status is ongoing. Affected quantity: 16329 (3880 US, 12449 OUS).

Recall Details

Product Type: Devices
Report Date: Sep 30, 2026
Initiation Date: Aug 12, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16329 (3880 US, 12449 OUS)

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).

Distribution Pattern

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.

Code Information

1. Model Number: HEWROOT0024; UDI-DI: 00384401013884; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 2. Model Number: HEWROOT0026; UDI-DI: 00384401013891; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 3. Model Number: HEWROOT0028; UDI-DI: 00384401013907; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 4. Model Number: HEWROOT0030; UDI-DI: 00384401013914; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 5. Model Number: HEWROOT0032; UDI-DI: 00384401013921; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life; 6. Model Number: HEWROOT0034; UDI-DI: 00384401013938; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;