June 30, 2022 — Today, the US Food and Drug Administration (FDA) issued updates from the FDA website to include information about recent recalls by: Medtronic† These recalls include information about battery performance issues and the availability of custom software for selected patients.
On June 3, 2021, Medtronic ceased sales and distribution of the HeartWare Ventricular Assist Device (HVAD) system due to the increased risk of death and neurological side effects in patients using the device, and a failure that may prevent the device from restarting. Both problems can lead to serious injury or death.
The FDA continues to work with Medtronic to ensure the health and safety of device users, which remains our top priority. This includes ensuring that current patients continue to receive appropriate follow-up monitoring and Medtronic continues to meet its commitments to support patients and caregivers.
Updates
June 30, 2022 – Medtronic has issued a recall to notify caregivers and patients of battery performance issues. All caregivers and patients are now being notified of the battery failure previously reported to affected healthcare providers in the May 2022 recall. Medtronic has also provided information about electrical failures in the battery caused by an interaction between the battery software and an internal component.
June 7, 2022 – Medtronic has launched a recall to inform healthcare providers tracking certain patients (those with a pump in the subgroup identified as having a higher risk of reboot failure) about a controller with custom software available as a backup -up if the pump is stopped and the default controller cannot restart the pump.
Additionally, Medtronic’s recent actions to correct translation and labeling errors have been added to the: Medtronic HeartWare recalls below:†
The FDA remains committed to providing updates on the safety profile of the HeartWare Ventricular Assist Device (HVAD) system. For more information: www.fda.gov
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