Class II U.S. Food and Drug Administration

Intervascular, Sas Cardioroot Woven Collagen Coated Vascular Graft recall: Product failed to meet the specified acceptance criteria for Integral Water

Recall published 25 days ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3258-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Intervascular, Sas
Product type
Medical devices
Units affected
16329 (3880 US, 12449 OUS)
Distribution
Nationwide
Made in
France
Lot / code info
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;
UPC codes
00384401013884, 00384401013891, 00384401013907, 00384401013914, 00384401013921, 00384401013938

Products covered by this recall

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

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00384401013884
  • 00384401013891
  • 00384401013907
  • 00384401013914
  • 00384401013921
  • 00384401013938

Model or item number

On the rating label, the box or the instruction sheet.

  • 1. HEWROOT0024
  • 2. HEWROOT0026
  • 3. HEWROOT0028
  • HEWROOT0024
  • HEWROOT0026
  • HEWROOT0028
  • HEWROOT0030
  • HEWROOT0032
  • HEWROOT0034

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Intervascular, Sas — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: INTERVASCULAR, SAS — 1 Zone Industrielle Athelia, La Ciotat Cedex

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Intervascular, Sas medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00384401013884, 00384401013891, 00384401013907; model number 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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