Special Alerts

Medical device manufacturer, Datascope, a subsidiary of Getinge, has issued a medical device corrective action concerning its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) [Product Code/Part Number:0998-00-0800-31; 0998-UC-0800-31; 0998-00-0800-32; 0998-00-0800-33; 0998-UC-0800-33; 0998-00-0800-34; 0998-00-0800-35; 0998-00-0800-45; 0998-00-0800-52; 0998-UC-0800-52; 0998-00-0800-53; 0998-UC-0800-53; 0998-00-0800-55; 0998-UC-0800-55; 0998-00-0800-65; 0998-00-0800-75; 0998-00-0800-83; 0998-00-0800-85; Manufacturing Dates: Since December 2011; Distribution Dates: Since March 06, 2012].

The manufacturer is initiating the voluntary medical device correction due to two issues that could affect IABP performance:

• Issue 1: There have been reports of IABP units losing the ability to charge batteries in one or both bay slots due to a failure in the Power Management Board Charging Path Circuitry. The failure was due to damage to the component from a previous electrical surge. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert user to the issue prior to interruption of therapy.
• Issue 2: An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 13 Jun 2023