Class I Recall of HeartWare HVAD System by Medtronic
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.
Medtronic sent a letter 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. For additional information about this recall, you may contact Medtronic Customer Service at 877-367-4823.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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