Open, Classified

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

FDA Recall Z-3258-2026 · Posted 2026-09-23

Recalling FirmINTERVASCULAR, SAS

Recall StatusOpen, Classified

Product CodeDSY

Date Initiated2026-08-12

Product Quantity16329 (3880 US, 12449 OUS)

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103347CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESESIntervascular Sas · 2011-02-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.