iVascular Navitian
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Life Vascular Devices Biotech S.L.
Cami De Can Ubach, Sant Vicenc Dels Horts, Barcelona, Spain, 08620
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