The U.S. Food and Drug Administration has issued a Class I recall for Datascope intra-aortic balloon pumps manufactured by Getinge (Wayne, New Jersey) after reports of batteries in the pumps failing to function correctly.
The FDA defines a Class I recall, the most serious type of recall, as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recall affects the following models: Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100/100i IABP.
The manufacturer initiated a “field correction” on May 16, and FDA issued the Class I recall Tuesday.
The FDA’s notice says that Getinge, which the agency refers to as Maquet/Datascope, issued its recall “due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time, which may cause the device to stop working when being operated by battery only.”
“If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death,” the FDA notice says. “Maquet/Datascope is aware of five patient deaths since March 2016, although the firm has not concluded that the deaths are due solely to the device shutting down while operating on battery power.”
The agency cited instructions sent by Getinge to affected customers, including ensuring that the balloon pump is plugged in to an AC power outlet when the system is not in use and whenever possible during use, having additional charged batteries on hand during transport, and replacing batteries as required and detailed in the instruction manual.
Clinicians or other providers and consumers may report problems to the FDA’s MedWatch program.