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 Arrow International LLC Subsidiary Of Teleflex Incorporated Ultra Intra-Aortic Balloon Pumps (IABP) [Ultra 8 Intra-Aortic Balloon - Lightwave Sensor (Model or catalog number: IAB-05830-LWS, IAB-05840-LWS); Ultra IABP Catheter Kit (Model or catalog number: IAB-05830-U, IAB-05840-U); UltraFLEX Intra-Aortic Balloon (Model or catalog number: IAB-06840-U, IAB-06830-U)] [HKMD No.: 210465].
According to Health Canada, the manufacturer is initiating this voluntary correction for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/ultra-intra-aortic-balloon-pumps-iabp
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 May 2024