Isleeve™ Expandable Introducer Set

iSLEEVE™ Expandable Introducer Set Recall The iSLEEVE™ Expandable Introducer Set is being recalled across Canada due to a performance issue. This medical device is used to help insert catheters and other instruments into blood vessels. The recall affects all iSLEEVE™ Expandable Introducer Sets distributed in Canada.

Product

iSLEEVE™ Expandable Introducer Set

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2024-02-29

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3d27c5bb-a402-4fd3-ac69-7bab6bbae4dc