10 Medtech Recalls that Shocked the Industry—Intra-Aortic Balloon Pumps

Some of the intra-aortic balloon pumps (IABP) made by Maquet Datascope Corporation were recalled in March 2014 because the device's fan assembly could malfunction and cause the device to stop with any alerts.

According to the FDA recall release, a malformed retaining ring in the fan assembly could make the fan stop. Without the fan cooling, the device's power supply could overheat and cause the pump to shut down.

Because IABPs work by inflating and deflating a balloon to temporarily help circulation and blood perfusion, device stoppage might have dire consequences for the heart and other organs.

According to FDA, Maquet Datascope received over 100 reports of device problems and one death.