iVascular Navitian Recall
Summary
Health Canada has issued a Type II recall for the iVascular Navitian medical device due to a potential risk of material fragment loss from outer layer deterioration. The recall affects specific lot and serial numbers and is being managed by the manufacturer, Life Vascular Devices Biotech S.L.
What changed
Health Canada has initiated a Type II recall for the iVascular Navitian medical device, identified by RA-81788. The recall is due to a post-market surveillance finding of deterioration of the outer layer of the distal segment, which could lead to the loss of material fragments, particularly in extremely calcified lesions. Affected products include specific lot numbers (2310773, 2305238, 2308456, 2308459) all with model number MCCC14135001.
Healthcare providers are advised to contact the manufacturer, Life Vascular Devices Biotech S.L., for additional information. This action highlights the importance of ongoing post-market surveillance for medical devices and the potential for material degradation issues to arise after a product has been released. While no specific compliance deadline is stated, healthcare providers should ensure they are aware of the affected lots and follow manufacturer guidance to mitigate patient risk.
What to do next
- Contact the manufacturer for additional information regarding the iVascular Navitian recall.
- Review affected lot and serial numbers for the iVascular Navitian device.
Archived snapshot
Mar 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
iVascular Navitian
Brand(s)
Life Vascular Devices Biotech S.L.
Last updated
2026-03-24
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:
2026-03-24
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
2026-03-11
Identification number RA-81788
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Source
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