Abbott Recalls Certain HeartMate Mobile Power Units Due to Unexpected Power Loss

The FDA has reported on a recall for HeartMate Mobile Power Units manufactured by Abbott due to “instances of sudden power loss.”

Users of the device are not to use MPUs “experiencing performance issues such as sudden loss of power and the visual / audio alarms” shown on the FDA webpage. Patients should be immediately switched to 14V rechargeable batteries, but “if the batteries are not connected to the System Controller within 15 minutes of MPU power loss, the System Controller Backup Battery will deplete, causing pump power loss.”

Healthcare providers should review the affected serial numbers list and, if possible, send a provided patient letter from Abbott to those patients. All patients should receive the patient letter if the specific serial numbers cannot be determined. Users who are not experiencing performance issues should be educated on the issue and have 14V rechargeable batteries ready for use.

Abbott received “reported incidents in which the MPU experienced sudden, unexpected performance issues such as not turning on, unprompted shut down, or suddenly turning off and restarting, with the System Controller indicating a Yellow Wrench alarm or ‘No External Power’ alarm.” Abbott has not reported any serious injuries or deaths associated with this issue at this time.