Abiomed, part of Johnson & Johnson MedTech, has issued a letter to affected customers recommending certain Automated Impella Controllers be removed from where they are used or sold after one patient death related to a device defect.
Abiomed said that certain Automated Impella Controllers 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.
In the case of capacitor failure in the Automated Impella Controller, an abrupt pump stoppage or decreased performance of the Automated Impella Controller may occur, potentially resulting in transient hemodynamic instability, loss of circulatory support, or death.
The Automated Impella Controller is the primary user control interface for the Impella Catheters. It controls the Impella Catheter and monitors the catheter for alarms. Impella therapy aims to reduce the work of the heart's left ventricle and provide support for the circulatory system so the heart has time to recover.
The full recall notice can be viewed here.
