Health Products

Hybrid Hydrophilic Microguidewire

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Hybrid Hydrophilic Microguidewire
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Hybrid Hydrophilic Microguidewire00635256HYBRID007J
Hybrid Hydrophilic Microguidewire00635712HYBRID007D
Hybrid Hydrophilic Microguidewire00636695HYBRID007D

Issue

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.

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