Intra-aortic balloon pumps recalled due to fluid leak issue
The FDA announced it designated a recall of intra-aortic balloon pumps due to problems related to fluid leak as class 1, the most serious type.
The recall by Getinge/Datascope/Maquet of the Cardiosave Hybrid/Rescue intra-aortic balloon pumps occurred after complaints of fluid leaks, as fluid entering the pump may cause it to shut down or for therapy to fail to be initiated, according to an alert from the FDA.
So far, there have been 71 complaints and one death associated with the issue, according to the alert. The recall covers 4,338 devices manufactured since December 2011 and distributed between March 6, 2012, and Oct. 21, 2021.
Customers are instructed to never place fluids on top of the unit, to wipe the unit clean and have it serviced immediately if there is accidental spillage and to use a plastic cover anytime the device is used outdoors, and the company plans to upgrade all devices in the field, according to the alert.
As Healio previously reported, the pumps were also recalled in October due to substandard batteries.