FDA Alerts

Class 1 Recall: Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Fri Jun 08 2018By Alexandra Wright

Recalled Product:

  • Name and Version: Medtronic HeartWare Ventricular Assist Device (HVAD system)
  • Manufacturing and Distribution Dates: March 2006 to May 2018
  • Devices Recalled in the U.S.: 204,017

All devices are affected by this recall and include the following products:

Device Name Model Numbers
(may include various suffixes)
Serial numbers
Controller/controller kits 1400, 1401, 1403, 1407, 1420 All
DC adapter 1435, 1440 All
AC adapter 1425, 1430 All
Battery pack 1650 All

Device Use

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.

The HeartWare Ventricular Assist System (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.

Reason for Recall

Medtronic is recalling the HeartWare HVAD because of the 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.

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.

Who May be Affected

Patients with end-stage heart failure. Patients who are completely dependent on the HVAD system for their cardiac output, such as patients with very low native heart ejection fraction, or those who have fused or surgically closed aortic valves, are at greatest risk of harm.

What to Do

Medtronic sent a letter on May 2, 2018disclaimer icon 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

In addition, FDA reminds patients to call 911 if they are experiencing a medical emergency. FDA also reminds patients whenever possible to have a trained caregiver nearby when changing power sources and/or controllers.

 

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