· Published by Health Canada · Official notice
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Hybrid Hydrophilic Microguidewire | 00635256 | HYBRID007J |
| Hybrid Hydrophilic Microguidewire | 00635712 | HYBRID007D |
| Hybrid Hydrophilic Microguidewire | 00636695 | HYBRID007D |
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.