The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.
Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board or Solenoid Board (Power Source Path).
Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death. Datascope/Maquet/Getinge reported 26 complaints. There have been no reports of injuries, or death.
On June 5, 2023, Datascope/Maquet/Getinge sent all affected customers an Important Medical Device Advisory.
The letter requested customers to:
• Ensure there is an alternative IABP available to continue therapy.
• Provide alternative hemodynamic support if there is no other means to continue
counterpulsation therapy.
Customers with questions about this recall should contact their Datascope/Maquet/Getinge
representative or call Datascope/Maquet/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1,
Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time).
Product Models:
• Distribution Dates: March 6, 2012 to May 19, 2023
• Devices Distributed in the U.S.: 4586
• Date Initiated by Firm: June 5, 2023
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
