FDA announces Class I recall of battery packs for intra-aortic balloon pumps
The FDA has announced that Datascope/Getinge/Maquet are recalling certain battery packs for the Cardiosave Hybrid and Rescue intra-aortic balloon pumps due to the batteries failing much quicker than originally advertised.
These devices are typically used when patients are undergoing surgery—cardiac or otherwise—or when they present with acute coronary syndromes or complications related to heart failure.
This is a Class I recall, meaning the use of these devices “may cause serious injuries or death.” There have been six total complaints about the issue at this time, but no injuries or deaths.
“If a patient requires life-supporting therapy with an intra-aortic balloon pump 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,” according to the FDA’s advisory.
The battery packs being recalled were distributed to customers from September 2017 to August 2021. The recall was first initiated on Sept. 21, 2021.
The full FDA advisory is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.