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FDA designates HVAD system recall as Class I

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The FDA has classified Medtronic’s voluntary action regarding the HeartWare ventricular assist system as a Class 1 recall, the most serious kind, according to statements released by the company and the FDA.

The recall impacts 16,399 HeartWare HVAD systems implanted as of May 22, 2018.

In May, the company alerted physicians about a possible transient interruption in the electrical connection between the power source for the HeartWare HVAD system and the HVAD controller, according to the company and the FDA.

The interruption leads the device to convert to a secondary power source, which may cause the HeartWare system to stop and restart. Inadvertent switching of the power source may also cause “unexpected audible tones” when electrical connection is restored, according to the company. This beeping, as it is referred to, can cause confusion among patients and caregivers, as the HVAD controller may still appear to have adequate battery function or AC/DC connectivity. A “critical battery alarm” may also appear.

Medtronic also made a lubricant solution available last month that can be applied to the HeartWare system’s power source connectors to manage unforeseen, transient switching of power. The lubricant is available through the company’s field representatives.

No reports of harm associated with this issue have been released. According to Medtronic, the per-patient probability of serious adverse events due to interruption of the electrical connection is approximately 0.003.

Medtronic issued the following recommendations to physicians and hospitals:

• Reinforce the importance of ensuring two power sources are connected at all times;
• Reinforce best practice guidance for managing power sources when going to sleep and upon awakening; and
• Instruct patients to report persistent, unexpected audible tones to the VAD team for further instructions.

The FDA also stated that patients should call 911 in the event of a medical emergency.

References:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609599.htm?utm_campaign=FDA%20MedWatch%20-%20HeartWare%20HVAD%20System%20by%20Medtronic%3A%20Class%20I%20Recall&utm_medium=email&utm_source=Eloqua. Accessed June 1, 2018.

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2352839. Accessed June 1, 2018.