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 Berlin Heart GmbH Excor System Cannulas [Model or Catalog Number: C14A-040M, C18A-020, C22A-004, C27A-001, C60G-002M, C85G-004, C80G-040M, C85G-002M, C60G-004M, C80G-021M, C15V-040M, C23V-004, C25V-004, C22V-002M, C19V-020M, C22V-004, A06-009, A09-012; All Lots][HKMD No.: 180212].
According to Health Canada, the manufacturer is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/excor-system-cannulas
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Aug 2023