July 24, 2019

FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious.

Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time, which may cause the devices to stop working when operating on battery only.

The company is aware of five deaths since March 2016, though the firm has not concluded that the deaths were due solely to the device.

Maquet/Datascope is currently developing a Cardiosave battery maintenance software upgrade targeted for early 2020.

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