INTERVASCULAR, SAS recalls Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4.
Intervascular recalls Cardioroot Woven Collagen Coated Vascular Grafts with model numbers HEWROOT0024-0034 due to failure in water permeability testing. Affected products may not meet quality standards.
Recall notice
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
What happened, in plain English
Intervascular is recalling Cardioroot Woven Collagen Coated Vascular Grafts with specific model numbers because they failed water permeability tests. This could mean the product doesn't meet quality standards, though the exact risk to users isn't specified in the recall. Read more at govinfonow.com/recall/1292602-intervascular-cardioroot-vascular-grafts-may-fail-water-permeability-test.
Source Summary by GovInfoNow · govinfonow.com/recall/1292602-intervascular-cardioroot-vascular-grafts-may-fail-water-permeability-test · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3258-2026
Cite this page
“Intervascular Cardioroot Vascular Grafts May Fail Water Permeability Test.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292602-intervascular-cardioroot-vascular-grafts-may-fail-water-permeability-test. Based on FDA recall #Z-3258-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3258-2026%22&limit=1).
Why it’s dangerous
The product failed to meet the required water permeability standards during testing. This could mean the grafts don't function properly in the body, potentially causing complications during vascular procedures. However, the recall does not specify how this failure might affect users in real-world use.
Who’s affected
Patients who received Cardioroot Woven Collagen Coated Vascular Grafts with model numbers HEWROOT0024 through HEWROOT0034 are likely affected. Medical professionals using these products for vascular surgery may also be at risk.
How to tell if you have this one
Check for model numbers HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, or HEWROOT0034 on the product label. All affected products were manufactured within their labeled shelf life.
- Brand
Intervascular- Category
Medical device
What to do — step by step
Check Product Model
Look for model numbers HEWROOT0024 through HEWROOT0034 on the product label.
Questions people ask
What is the specific problem with these vascular grafts?
The product failed to meet the specified water permeability standards during testing, which may indicate it doesn't function properly in the body.
Do I need to stop using these grafts?
The recall does not specify that users should stop using the product; it only states the product failed water permeability tests.
How can I find out if my graft is affected?
Check the product label for model numbers HEWROOT0024 through HEWROOT0034. All affected products were manufactured within their labeled shelf life.
Contact Intervascular
We’ve drafted a message you can send Intervascular to request your refund or repair — edit it as you like.
Subject: Recall Z-3258-2026 — Intervascular Intervascular Hello, I own a Intervascular that is covered by recall Z-3258-2026 from Intervascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3258-2026 (August 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3258-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.