CanadaiVascular Navitian devices from Life Vascular Devices Biotech S.L., model/catalogue MCCC14135001, lots/serial numbers 2310773, 2305238, 2308456 and 2308459 are affected. Post‑market surveillance identified deterioration of the outer layer of the thinner distal segment that could lead to loss of material fragments when used in extremely calcified lesions. Contact the manufacturer for additional information.
What's being recalled
Companies: Life Vascular Devices Biotech S.L., Cami De Can Ubach, Sant Vicenc Dels Horts, Barcelona, Spain, 08620.
How to identify it
Affected products: iVascular Navitian; Lot or serial number: 2310773; Model or catalogue number: MCCC14135001
Affected products: iVascular Navitian; Lot or serial number: 2305238; Model or catalogue number: MCCC14135001
Affected products: iVascular Navitian; Lot or serial number: 2308456; Model or catalogue number: MCCC14135001
Affected products: iVascular Navitian; Lot or serial number: 2308459; Model or catalogue number: MCCC14135001
The hazard
A potential risk has been identified through post-market surveillance: deterioration of the outer layer of the thinner distal segment of the device, which could lead to the loss of material fragments when used in extremely calcified lesions.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)