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

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.

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 NameModel Numbers
(may include various suffixes)
Serial numbers
Controller/controller kits1400, 1401, 1403, 1407, 1420All
DC adapter1435, 1440All
AC adapter1425, 1430All
Battery pack1650All

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.

Contact Information

Customers who need additional information about this recall can contact:

Medtronic Customer Service
8200 Coral Sea St., NE
Mounds View, MN 55112

Phone: 877-367-4823

Full List of Affected Devices

Full list of affected devices is available in the FDA recalls database.

Date Recall Initiated:

May 2, 2018

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.