iVascular Navitian
Brand(s)
Last updated
Summary
Product
iVascular Navitian
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 |
|---|---|---|
| iVascular Navitian | 2310773 | MCCC14135001 |
| iVascular Navitian | 2305238 | MCCC14135001 |
| iVascular Navitian | 2308456 | MCCC14135001 |
| iVascular Navitian | 2308459 | MCCC14135001 |
Issue
A potential risk has been identified through post-market surveillance: deterioration of the outer layer of the thinner distal segment of the device, which could lead to the loss of material fragments when used in extremely calcified lesions.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Life Vascular Devices Biotech S.L.
Cami De Can Ubach, Sant Vicenc Dels Horts, Barcelona, Spain, 08620
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81788
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