FDA: Class I recall of HeartWare Ventricular Assist Device Pumps

Editor's Note

The Food and Drug Administration on October 24 categorized HeartWare Inc’s recall of its HeartWare Ventricular Assist Device Pumps as Class I, the most serious.

The recall is because of a design problem with the driveline connector that connects the pump to the external controller and power source.

Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse patient events, including death. 

Posted 10/24/2016] AUDIENCE: Risk Manager, Nursing ISSUE: HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source.