Z-3258-2026Class II

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3...

Name: Z-3258-2026 Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3...
Creator: Intervascular, Sas
Published: 2026-08-12
License: https://open.fda.gov/license/

Intervascular, Sas / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3258-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-09-23
Recalling firm: Intervascular, Sas
Product: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
FDA root cause: Under Investigation by 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.
Quantity in commerce: 16329 (3880 US, 12449 OUS)
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 codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3258-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3258-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-23

Product code DSY

K103347Class IICardioroot Woven Collagen Coated Vascular ProsthesesIntervascular Sas / cleared 2011-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)