CanadaThe Hybrid Hydrophilic Microguidewire from Balt Extrusion SAS — Hybrid007 models HYBRID007J (lot 00635256) and HYBRID007D (lots 00635712 and 00636695) — is affected. Performance variability of the hydrophilic coating may increase friction during microcatheter navigation, possibly requiring guidewire replacement, prolonging procedure time and increasing the risk of procedure-related complications; contact the manufacturer for additional information.
What's being recalled
Companies: Balt Extrusion SAS, 10, Rue Croix-Vigneron, Montmorency, France, 95160.
How to identify it
Affected products: Hybrid Hydrophilic Microguidewire; Lot or serial number: 00635256; Model or catalogue number: HYBRID007J
Affected products: Hybrid Hydrophilic Microguidewire; Lot or serial number: 00635712; Model or catalogue number: HYBRID007D
Affected products: Hybrid Hydrophilic Microguidewire; Lot or serial number: 00636695; Model or catalogue number: HYBRID007D
The hazard
Performance variability affecting the hydrophilic coating of Hybrid007 guidewires in specific lots may increase friction during microcatheter navigation. This may require guidewire replacement to complete the procedure, potentially prolonging procedure time and increasing the risk of procedure-related complications.
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)