Cardioroot recallZ-3258-2026 · Intervascular, Sas · initiated Aug 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intervascular, Sas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-3258-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2026
- Posted by the FDA
- Sep 23, 2026
- Recalling firm
- Intervascular, Sas
- Quantity
- 16329 (3880 US, 12449 OUS)
- Product code
- DSY
- FDA submissions
- K103347
- Distribution
- 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.
Product description
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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;
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- Cardioroot HEWROOT0028Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall6 reports
- Cardioroot HEWROOT0026Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall4 reports
- Cardioroot HEWROOT0034Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall1 death2 reports
- Cardioroot HEWROOT0024Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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