FDA Class I Recall: HeartWare HVAD battery cables, data cables, adapter cables and controller 2.0 Ports by Medtronic
Medtronic is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the Controller port metal pins (for example, bent pins), reported the U.S. Food and Drug Administration (FDA).
Damaged controller ports may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump. This could cause serious patient harm including loss of consciousness, hospitalization, heart attack, or death. There have been 855 complaints about this device issue and eight reports of injuries. Twelve deaths have been reported.
The HeartWare Ventricular Assist Device (HVAD) Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports are part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.
