One June 1, 2018, the U.S. Food and Drug Administration (FSDA) issued a Class 1 recall alert for the Medtronic HeartWare HVAD System because of the possibility of interruption in the electrical connection between the system's power source (the 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."

According to the announcement, "all devices are affected by this recall."

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

Table of Affected Devices

Device NameModel Numbersa Serial Numbers

Controller/controller kits1400, 1401, 1403, 1407, 1420All

DC adapter1435, 1440All

AC adapter1425, 1430All

Battery pack1650All

aMay include various suffixes.

[su_spacer size="30"]

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

The 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."

For the more information, visit the FDA recall database post.