FDA Alert on Abiomed Impella Controllers

FDA has issued an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed from where they are used or sold. The company stated that affected devices have a pump driver circuit assembly that does not meet current specifications. “These pump driver circuit assemblies contain 25v-rated tantalum capacitors instead of 35v-rated tantalum capacitors which may lead to decreased pump performance or pump stop and trigger an ‘Impella Failure’ or ‘Impella Stopped — Controller Failure’ alarm,” the alert says. To date, Abiomed has reported one death and no serious injuries associated with this issue, it adds.

The automated Impella controller is the primary user control interface for Impella heart catheters, the alert says. Impella therapy is intended to reduce the work of the heart’s left ventricle and provide support for the circulatory system so the heart has time to recover.