Public recall detail

LEO+ Intracranial Self Expandable Stent And Delivery System

2026-09-02

medium
Health products Health product recall
Quick summary

Quick summary: LEO+ Intracranial Self Expandable Stent And Delivery System. Reason: Health product recall. Category: Health products. Date: 2026-09-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: LEO+ Intracranial Self Expandable Stent And Delivery System. Reason: Health product recall. Category: Health products. Date: 2026-09-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBalt Extrusion Sas
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82588

Affected products

ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00644632
ModelLEO.3.5X25
Serial number00644632
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645585
ModelLEO.3.5X25
Serial number00645585
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00633163
ModelLEO.3.5X25
Serial number00633163
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00650473
ModelLEO.3.5X25
Serial number00650473
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645903
ModelLEO.3.5X25
Serial number00645903
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00648969
ModelLEO.3.5X25
Serial number00648969
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00644632
ModelLEO.4.5X30
Serial number00644632
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645585
ModelLEO.4.5X30
Serial number00645585
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00633163
ModelLEO.4.5X30
Serial number00633163
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00650473
ModelLEO.4.5X30
Serial number00650473
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645903
ModelLEO.4.5X30
Serial number00645903
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00648969
ModelLEO.4.5X30
Serial number00648969
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00644632
ModelLEO.4.5X20
Serial number00644632
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645585
ModelLEO.4.5X20
Serial number00645585
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00633163
ModelLEO.4.5X20
Serial number00633163
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00650473
ModelLEO.4.5X20
Serial number00650473
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645903
ModelLEO.4.5X20
Serial number00645903
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00648969
ModelLEO.4.5X20
Serial number00648969
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00644632
ModelLEO.5.5X35
Serial number00644632
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645585
ModelLEO.5.5X35
Serial number00645585
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00633163
ModelLEO.5.5X35
Serial number00633163
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00650473
ModelLEO.5.5X35
Serial number00650473
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645903
ModelLEO.5.5X35
Serial number00645903
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00648969
ModelLEO.5.5X35
Serial number00648969
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00644632
ModelLEO.3.5X35
Serial number00644632
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645585
ModelLEO.3.5X35
Serial number00645585
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00633163
ModelLEO.3.5X35
Serial number00633163
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00650473
ModelLEO.3.5X35
Serial number00650473
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00645903
ModelLEO.3.5X35
Serial number00645903
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System
ProductLEO+ Intracranial Self Expandable Stent And Delivery System
Lot00648969
ModelLEO.3.5X35
Serial number00648969
DescriptionLEO+ Intracranial Self Expandable Stent And Delivery System

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesBalt Extrusion Sas 10, Rue Croix-Vigneron, Montmorency, France, 95160
Recall date2026-08-20
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82588
Background{}
CompaniesBalt Extrusion Sas 10, Rue Croix-Vigneron, Montmorency, France, 95160
AudiencesHealthcare
Source updated2026-09-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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