Recall Monitor
Health Products

LEO+ Intracranial Self Expandable Stent And Delivery System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: LEO+ Intracranial Self Expandable Stent And Delivery System
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
LEO+ Intracranial Self Expandable Stent And Delivery System00644632LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00645585LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00633163LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00650473LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00645903LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00648969LEO.3.5X25
LEO+ Intracranial Self Expandable Stent And Delivery System00644632LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00645585LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00633163LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00650473LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00645903LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00648969LEO.4.5X30
LEO+ Intracranial Self Expandable Stent And Delivery System00644632LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00645585LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00633163LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00650473LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00645903LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00648969LEO.4.5X20
LEO+ Intracranial Self Expandable Stent And Delivery System00644632LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00645585LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00633163LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00650473LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00645903LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00648969LEO.5.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00644632LEO.3.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00645585LEO.3.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00633163LEO.3.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00650473LEO.3.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00645903LEO.3.5X35
LEO+ Intracranial Self Expandable Stent And Delivery System00648969LEO.3.5X35

Issue

As a precautionary measure, Balt Extrusion is voluntarily recalling specific ANRYV connector lots after routine quality control identified non-conforming bacterial endotoxin test results. The recall affects both standalone ANRYV connectors and ANRYV connectors incorporated into selected Balt product kits, despite no reported patient harm to date.

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