In late January, the agency said about 4,500 of the cardiac devices were recalled because of a risk of the balloon breaking, which can cause a device shutdown if blood enters the pump. Four serious injuries and one death were reported with the recall. None of the other recalls for the balloon pumps have reported injuries or deaths.
Unexpected shutdowns from coiled cord connection failures and circuit board communication issues led to two other recalls of about 6,800 devices in March.
In August, the FDA reported another recall. The most recent case involved about 4,500 devices because of a risk of sudden power failure, and the agency said Aug. 17 the power issues were due to the device’s printed circuit board assembly in the charging path.
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