Health product recall

Hybrid Hydrophilic Microguidewire

Last updated

Summary

Product
Hybrid Hydrophilic Microguidewire
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

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

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Balt Extrusion SAS
10, Rue Croix-Vigneron, Montmorency, France, 95160
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82279

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