The FDA published a recall notice stating that Datascope/Getinge/Maquet has initiated a recall of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump battery packs due to a defect that causes some batteries to fail. The recall notice states that the packs contain substandard batteries that do not meet the performance specifications that were described to customers. The battery packs have a reduced run-time, which could cause the intra-aortic balloon pump to stop working when the device is operated by the battery only.
These medical devices are usually used while patients are undergoing cardiac surgery or when a patient suffers from acute coronary syndromes or complications linked with heart failure. The FDA states that this is a Class I recall. A Class I recall means the recalled device “may cause serious injuries or death.”
Datascope/Getting/Maquet has received six incident reports complaining of the defect. At this time, no reports of injuries or deaths related to the recall have been reported. However, the recall notice states that there is a “potential for underreporting since the end-user reporting a failed battery or short battery-run time cannot be aware that they originally received a substandard battery.” In other words, some battery packs for the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps contain batteries that are failing faster than originally advertised to patients.
The FDA’s advisory states that when a patient needs “life-supporting therapy with an intra-aortic balloon pump” and the medical device fails to work, or therapy is stopped due to battery failure, the patient could sustain a serious injury or perish.
The recalled intra-aortic balloon pump battery packs were distributed to consumers from September 2017 to August 2021. The FDA’s complete advisory is available here.
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