Recall Monitor
Health Products

iVascular Navitian

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: iVascular Navitian
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
iVascular Navitian2310773MCCC14135001
iVascular Navitian2305238MCCC14135001
iVascular Navitian2308456MCCC14135001
iVascular Navitian2308459MCCC14135001

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.

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