Getinge is recalling 137 battery packs for its intra-aortic balloon pump after discovering some of the battery packs don't work properly and could cause the device to stop working.
The FDA said Oct. 29 that Getinge is recalling its Cardiosave Hybrid/Rescue intra-aortic balloon pump battery packs because the substandard battery packs don't meet performance standards. The agency has defined the recall as class 1, the most serious type of recall, meaning use of the device could cause serious injury or death.
Getinge has received six complaints related to the recall issue, but no reports of injury or death. The FDA said there is potential for underreporting because users may not know they received a substandard battery pack.
The intra-aortic balloon pump is used to treat adults with acute coronary syndrome or heart failure complications. The substandard battery packs may cause the device to stop working when operated by battery only. If the device stops working during use, the patient is at risk of serious injury or death.
The FDA said customers should examine their inventory and immediately replace any affected battery packs.
Read the full news release here.