Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0…
INTERVASCULAR, SAS · Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Open FDA's page for this record- Cfres ID
- 222393
- Product res number
- Z-3258-2026
- Event date initiated
- 2026-08-12
- Event date posted
- 2026-09-23
- Recall status
- Open, Classified
- Res event number
- 99745
- Product code
- DSY
- Product description
- Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
- Firm FEI number
- 3002707083
- Recalling firm
- INTERVASCULAR, SAS
- Address 1
- 1 Zone Industrielle Athelia
- City
- La Ciotat Cedex
- Country
- France
- Reason for recall
- Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
- Root cause description
- Under Investigation by firm
- Product quantity
- 16329 (3880 US, 12449 OUS)
- 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;
- 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.
- Distribution pattern
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.
- K numbers
- K103347
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3450
- Device class
- 2
- K number
- K831822, K232312, K831865, K940816, K150389, K013250, K141124, K905269, K130142, K760091, K231972, K910864, K043552, K122138, K903964, K901682, K862739, K060124, K060741, K233783, K001927, K021547, K760090, K991813, K821158, K183613, K861808, K821716, K800149, K933987, K002007, K910865, K013577, K871110, K880167, K983064, K202471, K862697, K050049, K992443 +148 more
- PMA number
- P840029
- Registration number
- 1220948, 1018233, 1640201, 3010162973, 1723241, 3033589330, 3010407203, 3010097171, 3015225571, 3006082230, 1724474, 3045042524, 1220477, 3007676031, 3013718163, 1721676, 2242352, 3012536737, 2020394, 3008307705, 9612515, 3011175548, 1720929, 3015309643, 2246552, 1721504, 3006950086, 2017233
- FEI number
- 1220948, 1018233, 3033589330, 3010407203, 3010097171, 3015225571, 3006082230, 3045042524, 1000517719, 3002707083, 1220477, 3002808437, 3007676031, 3003094851, 3002807041, 1721676, 3013718163, 2242352, 3012536737, 2020394, 3008307705, 3011175548, 1720929, 3015309643, 2246552, 1721504, 3006950086, 2017233