FDA classifies HeartWare HVAD systems unexpected power source switching as Class I recall

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The United States Food and Drug Administration (FDA) has classified Medtronic recent voluntary urgent field action related to the HeartWare HVAD System unexpected power source switching as a Class I recall. Class I recalls describe situations where there is reasonable risk of serious adverse health consequences or death.

There have been no confirmed reports of catastrophic harm associated with this issue. The per patient probability of serious adverse events due to this issue is approximately 0.003. This recall affects 16,399 HeartWare Ventricular Assist Device (HVAD) Systems implanted as of May 22, 2018.

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.

In a notification letter distributed in May 2018, Medtronic alerted clinicians worldwide about a potential transient interruption of the electrical connection between a HeartWare HVAD System power source and the HVAD Controller, which results in unintended switching to the device’s secondary power source and could cause the System to momentarily stop and restart. In addition, unintended power switching can result in unexpected audible tones (“beeping”). This beeping, which occurs when the electrical connection interruption automatically resolves, may confuse the patient or caregiver, as the Controller may display sufficient battery capacity or AC/DC connectivity at the time of the audible tone. Also, a Critical Battery Alarm may be momentarily incorrectly displayed due to this phenomenon.

Patients do not need to take any action other than to follow patient management recommendations provided by their clinicians to effectively manage the HVAD System power source for this unexpected power switching issue.

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