FDA Issues Update on Getinge’s Intra-Aortic Balloon Pumps

The FDA received dozens of additional medical device reports involving shutdowns of Getinge’s intra-aortic balloon pumps while running them on battery power, the agency said, in an update.

The agency previously announced in November 2018 that there were reports of Getinge’s Maquet/Datascope devices Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i turning off while on battery power, leading to the loss of hemodynamic support.

Since its November 2018 announcement, two patient deaths and one serious patient injury have occurred in critically-ill patients using the device, the agency said, noting that the company is working on a battery maintenance software upgrade.