Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Cordis Corporation ANGIOGUARD RX Emboli Capture Guidewire System [Model or Catalog Number: 601814RE, 501814RE; Lot or Serial Number: 35264226, 35264224] [HKMD No.: 080127].
According to Health Canada, the manufacturer is recalling specific lots of ANGIOGUARD RX / XP Emboli Capture Guidewire System. The manufacturer has identified that there is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath. The potential impacts of separation include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke, while a replacement device is prepared.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/angioguardtm-rx-emboli-capture-guidewire-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Mar 2023