Image of the device showing the internal HVAD pump, which is connected to the external controller by a driveline cable through the skin. The controller is connected externally to the monitor, the AC adapter, and the battery.
June 4, 2018 — The U.S. Food and Drug Administration said Medtronic initiated a Class 1 recall all 204,017 of its HeartWare Ventricular Assist Devices (HVAD) produced between March 2006 to May 2018.
Medtronic said there is a possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption to the electrical connection, which occurs when the power source is still physically connected, is caused by oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. The interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death.
The HeartWare HVAD is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from end-stage left ventricular heart failure. It functions as a pump that helps the heart deliver blood to the rest of the body. The HeartWare system is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter. These indications have been expanded to include HVAD use for myocardial recovery, or as destination therapy in patients for whom subsequent transplantation is not planned.
Medtronic said the recall encompasses all HVAD systems manufacturing and distribution between March 2006 to May 2018, which includes 204,017 devices in the United States.
Medtronic sent a letter on May 2, 2018 advising hospitals and physicians to:
• Reinforce the importance of always ensuring two power sources are connected at all times
• Reinforce best practice guidance for managing power sources when going to sleep and awakening
• Instruct patients to report any persistent, unexpected audible tones to the VAD team for additional instructions
The FDA released a public statement about the HVAD recall June 4.
Customers who need additional information about this recall can contact Medtronic Customer Service at (877) 367-4823
This is the second major LVAD recall in the past month. In May, Abbott has initiated a Class I recall of more than 4,000 HeartMate 3 Left Ventricular Assist systems due to a malfunction in the device’s outflow graft assembly. The company said the malfunction may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.