FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note

The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious.

The FDA posted four recalls for four separate reasons:

• Because they may overheat when the device’s internal temperature exceeds 176 degrees Fahrenheit. This will generate a System Over Temperature alarm that puts the device in standby mode, and the pump then stops providing therapy. Between January 1, 2021, and June 2, 2023, the company has reported 213 complaints, including four injuries and one death, related to this issue.
• Because an Autofill Failure alarm may put the device in standby mode resulting in therapy interruption. Between January 1, 2021, and June 2, 2023, the company has reported 298 complaints, including two deaths and three injuries, related to this issue.
• Because the pumps may stop unexpectedly due to Gas Gain or Gas Loss alarms. Between January 1, 2021, and June 2, 2023, the company has reported 198 complaints, including two deaths and three injuries, related to this issue.
• Because of unexpected shutdowns related to incorrect docking of the IABP console into the cart (Hybrid Mode). Between January 1, 2021, and June 2, 2023, the company has reported 533 complaints, including one death, related to this issue.

Distribution dates for the devices were March 6, 2012, to May 19, 2023. The recalls are voluntary corrections by the company, not a product removal.