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U.S. Department of Health and Human Services

Class 2 Device Recall CARDIOROOT Woven

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 Class 2 Device Recall CARDIOROOT Wovensee related information
Date Initiated by FirmAugust 12, 2026
Date PostedSeptember 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3258-2026
Recall Event ID 99745
510(K)NumberK103347 
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
ProductCardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
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;
FEI Number 3002707083
Recalling Firm/
Manufacturer		 INTERVASCULAR, SAS
1 Zone Industrielle Athelia
La Ciotat Cedex France
Manufacturer Reason
for Recall		Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce16329 (3880 US, 12449 OUS)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DSY
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