Third Class I Recall in Less Than a Year for Cardiosave IABP

Datascope/Maquet/Getinge’s Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump (IABP) is seeing a recall deemed class I — the most serious type of recall as use of the device may cause serious injury or death — for the third time in the past nine months, this time for a potential electrical shutdown.

The device is used to inflate and deflate intra-aortic balloons which provide temporary support to the left ventricle for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

The IABP may shut down unexpectedly as a result of an electrical failure in the power management board or solenoid board, the FDA said, leading to unstable blood pressure, inadequate blood supply or vital organ injury and possibly death.

Previously, the company recalled the device on Dec. 19, 2022, because a compromised balloon could cause blood to enter the device and also cause a shutdown, with the recall deemed class I. Then, on Jan. 9, the company recalled the device warning that the coiled cable connecting the display and base on some units may fail, causing a shutdown, also deemed class I by the FDA.

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