INTERVASCULAR, SAS recalls Cardioroot Woven Collagen Coated Vascular Graft

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

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

On August 12, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Ensure all affected product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Always report any adverse events potentially related to the affected products to your Getinge representative.

• FDA enforcement recordOfficial FDA database entry for Z-3258-2026
• FDA 510(k) clearance · K103347The device's official FDA premarket clearance record
• FDA device classification · DSYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.3450The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find INTERVASCULAR, SASSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.