Recalls Related to the HVAD System

The FDA approved the Medtronic HeartWare Ventricular Assist Device (HVAD) System on November 20, 2012, as a bridge to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure. The FDA also approved the HVAD System for destination therapy on September 27, 2017, in patients for whom a heart transplant is not planned.

Since the HVAD System's approval in 2012, the agency has continued to monitor the product's safety and effectiveness by reviewing medical literature, clinical trial information, data from studies conducted after the device was FDA-approved, called post-approval studies, and medical device reports submitted to the agency.

A timeline and summary of FDA activities related to the HVAD system and Medtronic HeartWare Recalls since June 2021 are provided below.

FDA Activities Related to the HVAD System

Date	Event
August 25, 2022	The FDA issued a recall notice indicating the FDA classified the June 2022 recall related to the increase in battery electrical faults due to an interaction between the battery software and an internal component as Class 1.
June 23, 2022	The FDA issued a recall notice indicating the FDA classified the May 2022 recall related to a welding defect affecting internal HVAD Battery components from a single lot as Class 1.
June 10, 2022	The FDA issued a recall notice indicating the FDA classified the April 2022 recall related to actions to alert healthcare providers to a possibility of a weld defect in the internal pump as Class 1.
April 28, 2022	The FDA issued a letter to health care providers to alert health care providers to the possibility that patients who have the Medtronic HVAD System and appear to present with pump thrombosis may have a weld defect in the internal pump causing the pump to malfunction.
August 12, 2021	The FDA issued a recall notice indicating the FDA classified the June 3, 2021 actions to stop the sale and distribution of the HVAD System as Class 1.
June 3, 2021	The FDA issued a letter to health care providers stating that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because: There is an increased risk of neurological adverse events and mortality associated with the internal pump. There is a potential for the internal pump to stop. If the internal pump stops, it may delay restarting or fail to restart.

Medtronic HeartWare Recalls

Since Medtronic ceased distribution of the HVAD system in June 2021, the company has voluntarily recalled certain HVAD Systems and/or components, including:

Date	Description
January 2023	Medtronic issued an Urgent Medical Device Correction to request that health care providers and patients return 12 batteries with serial numbers listed in the letter due to battery tab welding defects. These batteries have electronic properties that may be indicative of a welding defect and Medtronic is requesting the return of these batteries to conduct further engineering analysis. The battery tab weld issue is the same issue that is described in the May 2022 and June 2022 communications.
November 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers that the driveline boot cover can become stiff over time. If the boot cover hardens, it can be difficult to disconnect the driveline from the controller. Medtronic is providing patient management recommendations, to include inspecting the boot cover routinely. Medtronic advises that hardened boot covers be reported to them so the need to perform a field service procedure to remove the cover can be discussed.
October 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers that a controller with modified software is available for all requesting hospitals as a back-up if the pump has stopped and the primary controller is unable to restart the pump. The pump failure to restart issue is the same issue that is described in the December 2021 communication, and the modified software is the same that is described in the June 2022 communication.
August 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers that they will begin exchanging HVAD power sources (batteries, AC and DC adapters) and Monitor data cables with new components that are intended to reduce the risk of damage on the Controller port metal pins. Medtronic previously communicated to health care providers about Controller port bent pins in February 2021. Medtronic is also informing health care providers that the device labeling has been updated with information on useful life and inspection of HVAD System components.
July 2022	Medtronic issued an Urgent Medical Device Correction to provide an update on their investigation into the pump weld defect issue, which was first communicated to health care providers in April 2022. Medtronic’s investigation was not able to identify a specific subset of pumps affected by this issue. Medtronic has also confirmed an additional complaint related to this issue.
June 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers and patients about two issues with the HVAD Battery. In May 2022, Medtronic recalled a single lot of batteries due to a welding defect affecting internal battery components. Medtronic is now informing all health care providers and patients about this welding defect issue to raise awareness and stress the importance of responding to alarms and removing faulty batteries from service. Medtronic identified an interaction between the battery software and an internal component that is causing an increase in battery electrical faults. Batteries with a battery electrical fault may be unable to power the controller, unable to accept charge from the battery charger, and/or appear to remain charged when in use. Medtronic has replaced the internal component for all new batteries being manufactured and is in the process of seeking regulatory approval for a change to the battery software.
June 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers who are following a patient with a pump in the subset identified at higher risk of experiencing a failure to restart that a controller with modified software is available as a back-up if the pump has stopped and the standard controller is unable to restart the pump. The pump failure to restart issue is the same issue that is described in the December 2021 communication.
May 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers of a welding defect affecting internal HVAD Battery components from a single lot (429 batteries total). Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.
April 2022	Medtronic issued an Urgent Medical Device Correction to inform health care providers of a pump weld defect that may present clinical signs and symptoms that resemble pump thrombosis. Medtronic is conducting an investigation to identify which HVAD pumps may be affected.
March 2022	Medtronic issued an Urgent Medical Device Communication to inform health care providers of a Finnish and Turkish language translation issue in the controller and monitor displays. These errors are also present in the Instructions for Use, Patient Manual, and Emergency Responder Guide. (See FDA Medical Device Recall Database Entry)
March 2022	Medtronic issued an Urgent Medical Device Communication to provide information correcting errors and inconsistencies, such as incorrect figures and translations, that were identified in the Instructions for Use, Emergency Responder Guide, and Patient Manual. (See FDA Medical Device Recall Database Entry)
February 2022	Medtronic issued an Urgent Medical Device Communication to inform health care providers that Medtronic has updated the cleaning instructions for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
December 2021	Medtronic issued an Urgent Medical Device Communication to provide an update on the failure rates associated with the pump failure to restart and additional data to assist in clinical decision-making for patients with a pump in the subset identified at higher risk of failure. Medtronic first issued an Urgent Medical Device Communication for this issue in December 2020. In May 2021, Medtronic also issued an Urgent Medical Device Communication to provide updated information regarding the December 2020 communication to assist health care providers in clinical decision-making regarding controller exchanges.
August 2021	Medtronic issued an Urgent Medical Device Communication to indicate that it may be more difficult to pull back the driveline cover after completion of a Driveline Strain Relief Repair.
June 2021	Medtronic issued an Urgent Medical Device Communication regarding the retrieval of a single non-implanted HVAD Pump Implant Kit containing a pump that did not meet the lower control limit for impeller shroud height. (See FDA Medical Device Recall Database Entry)
June 2021	Medtronic issued an Urgent Medical Device Communication to inform health care providers that Medtronic has stopped the distribution and sale of its HVAD System.

For all HeartWare related recalls prior to June 2021, please visit the FDA Medical Device Recalls Database.