RecallReported September 30, 2026
Class II recall by INTERVASCULAR, SAS
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT00…
FDA's enforcement report of September 30, 2026 lists a Class II recall by INTERVASCULAR, SAS of La Ciotat Cedex, France. Product: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT00…. Status: Ongoing.
On the record
- Recalling firm
- INTERVASCULAR, SAS
- Location
- La Ciotat Cedex, France
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3258-2026
- Product type
- Devices
- Recall initiated
- 2026-08-12
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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