Hybrid Hydrophilic Microguidewire
Brand(s)
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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