The US Food and Drug Administration (FDA) is updating healthcare providers on device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pumps (IABPs), including the Cardiosave Hybrid and Rescue, CS300, and CS100/CS100i devices.
The agency says it recently became aware that the Maquet/Datascope Cardiosave Hybrid and Rescue devices may not recognize alternating current (AC) power when plugged in and may unexpectedly shut down, according to a letter posted on the FDA’s website.
The FDA warned providers beginning in November 2018 that the Maquet/Datascope IABPs may be at risk of shutting down while running on batteries after receiving more than 75 reports, including five deaths, since 2016. Getinge initiated a voluntary recall in 2019 to conduct training visits and review battery reference guides with users.
Troubles have mounted, with the manufacturer issuing three voluntary recalls since September 2021 related to potential device failure with the Cardiosave Hybrid and Rescue IABP devices. They include:
A class II recall warning that the Cardiosave IABP devices may unexpectedly shut down when the device is running on AC power, when only one battery is installed, and when the battery is removed during charging.
A class I recall that certain Cardiosave Li-Ion battery packs may have shortened battery run time and should not be used.
A class I recall issued last week for fluid leaks that may cause unexpected pump shutdown or inability to initiate therapy.
“The FDA wants to ensure that healthcare providers and users of Maquet/Datascope Cardiosave IABP devices are aware of the potential for unexpected shutdown events and the manufacturer’s notices about the recent recalls,” the agency said today.
“While the FDA remains concerned about device shutdown events associated with Maquet/Datascope IABP devices, the FDA recognizes that these systems may be the best option for circulatory support for some patients,” it added.
The updated notice reiterates the FDA’s November 2019 recommendations for Maquet/Datascope IABP device users and servicers.
It also encourages providers to report any adverse events related to the recalled Getinge Maquet/Datascope IABP devices to the FDA through MedWatch, its adverse-event reporting program.
“The FDA continues to work with the manufacturer to examine and address the root causes of Maquet/Datascope Cardiosave IABP device failures while running on battery power or AC power and will keep the public informed if any significant new information or recommendations become available,” the agency said.