October 18, 2022 — The U.S. Food and Drug Administration (FDA) is providing updates to the FDA website to include information on recent recalls conducted by Medtronic. Medtronic announced that a backup controller with modified software, which may be used in certain circumstances if the primary controller fails to restart the pump, is available to all requesting hospitals. More information is available in the Medtronic Urgent Medical Device Correction Letter.
June 30, 2022 — Today, the U.S. Food and Drug Administration (FDA) is providing updates to the FDA website to include information on recent recalls conducted by Medtronic. These recalls include information on battery performance issues as well as the availability of a modified software for select patients.
On June 3, 2021, Medtronic stopped the sale and distribution of the HeartWare Ventricular Assist Device (HVAD) system given the increased risk of mortality and neurological adverse events in patients using the device, and a malfunction where the device may fail to restart. Both problems may lead to serious injuries or death.
The FDA continues to work with Medtronic to ensure the health and safety of device users, which remains our highest priority. This includes ensuring current patients continue to receive appropriate follow up monitoring and Medtronic continues to meet its obligations to support patients and health care providers.
Updates
June 30, 2022 – Medtronic conducted a recall to inform health care providers and patients of battery performance issues. All health care providers and patients are now being made aware of the battery welding defect that was previously communicated to affected providers in the May 2022 recall. Medtronic also provided information about battery electrical faults caused by an interaction between the battery software and an internal component.
June 7, 2022 – Medtronic initiated a recall to inform health care providers who are following certain patients (those with a pump in the subset identified at higher risk of experiencing a failure to restart) about a controller with modified software that is available as a back-up if the pump has stopped and the standard controller is unable to restart the pump.
Additionally, the recent actions taken by Medtronic to correct translation and labeling errors have been added to the Medtronic HeartWare Recalls below.
The FDA remains committed to providing updates about the safety profile of the HeartWare Ventricular Assist Device (HVAD) System. For more information: www.fda.gov
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