Intervascular Recalls Cardioroot Woven Collagen Coated Vascular Grafts
Intervascular is recalling Cardioroot Woven Collagen Coated Vascular Grafts because the product failed to meet acceptance criteria for Integral Water Permeability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to meet specified acceptance criteria, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Intervascular, SAS is recalling Cardioroot Woven Collagen Coated Vascular Grafts, including model numbers HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, and HEWROOT0034. The recall involves 16,329 units, with 3,880 units distributed in the United States and 12,449 units distributed outside the United States. The products were distributed worldwide, including in the US and numerous international countries.
The recall was initiated because the product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). The source text does not specify the exact nature of the failure or any reported adverse health consequences.
Healthcare providers and facilities should identify and remove these specific model numbers from use. Consumers are advised to contact their healthcare provider or the recalling firm for further instructions regarding the affected devices.
The recalled product
- Product
- Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
- Manufacturer
- INTERVASCULAR, SAS
- Category
- Medical Device — Vascular Graft
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
- 3. Model Number: HEWROOT0028
- UDI-DI: 00384401013907
- 4. Model Number: HEWROOT0030
- UDI-DI: 00384401013914
- 5. Model Number: HEWROOT0032
- UDI-DI: 00384401013921
- 6. Model Number: HEWROOT0034
- UDI-DI: 00384401013938
Distribution
Distributed nationwide across the United States.
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