Update: August 25, 2023
Please see Medtronic's August 23, 2023, Urgent Medical Device Communication for updated patient management recommendations for HeartWare Ventricular Assist Device (HVAD) systems. The FDA agrees with Medtronic's recommendations and references select recommendations below and on the Recalls Related to HVAD System page.
While no new patients have received the HVAD system since Medtronic stopped the sale and distribution in June 2021, we are sharing this new information that impacts certain patients who already have HVAD systems.
- Medtronic's Urgent Medical Device communication describes a newly identified subgroup of HVAD pumps defined by serial numbers (subgroup 3) that have a higher risk of failure to restart than the general population of patients with HVAD pumps.
- Patients in a subgroup should contact their VAD coordinator if they need to make a controller exchange so that the exchange can take place in a clinical setting.
This page contains recommendations for both patients implanted with the HeartWare Ventricular Assist Device (HVAD) System and health care providers monitoring patients with HVAD Systems. This page also describes how to report problems to the FDA.
Choosing to remove an implanted Medtronic HVAD System without a medically necessary reason is not recommended at this time. The risks associated with removing an implanted Medtronic HVAD System are higher than the potential benefits. Decisions about removing or exchanging the Medtronic HVAD System should be made by patients and health care providers together, considering the patient's clinical status and surgical risks.
Recommendations for Patients
- Follow the instructions in the Patient Manual.
- Keep your VAD coordinator informed of any concerns with your device, including alarms, damage, dirt and grime, batteries taken out of service, intermittent problems, carrying case wear, power adapter issues, etc.
- Always keep two sources of power connected to your controller and have charged, spare batteries and a backup controller with you at all times.
- When changing power sources, never disconnect both power sources at the same time. Complete changing one power source before working on the other.
- If a Power Disconnect alarm happens while a battery is connected to your device, replace the battery as soon as possible and do not use the battery again, and then notify your VAD coordinator.
- Each week, check your controller for dirt and grime as described in Section 7.2 Care of Your Controller and check your batteries for physical damage as described in Section 7.3 Care of Your Batteries. Do not clean the pins of the Controller AC Adapter, DC adapter, or Battery connectors. If the connector pins have any dirt or grime, use another method of powering the device if possible and notify your VAD coordinator.
- Investigate and, if possible, correct the cause of any alarms. Notify your VAD coordinator of any high or medium priority alarms, any alarms that cannot be resolved, or any alarms that may resolve too quickly to identify.
- Contact your VAD coordinator for necessary replacement components (for example, controllers, batteries, AC/DC adapters, carrying case), which will continue to be made available by Medtronic.
- Be mindful that HVAD power sources are designed and tested to function for a specific period of time, which is called the useful life. The device labeling identifies the useful life for each power source as:
- AC (wall) power adapter: Six months
- DC (car) power adapter: One year
- Battery: 500 charge and discharge cycles (this should provide patient support for one year)
- Report any adverse events or suspected events experienced with the Medtronic HVAD System to FDA. Please see below for how to report problems to FDA.
- If you have patients with HeartWare HVAD systems in subgroups 1, 2, or 3, as described by pump serial numbers in Medtronic's Urgent Medical Device Communications linked below, refer to Medtronic's August 23, 2023, Urgent Medical Device Communication Notification for complete patient management recommendations for these subgroups. Recommendations from the letter include:
- Speak with your patients to emphasize the importance of avoiding unnecessary pump stops.
- Instruct your patients to contact their VAD coordinator before they make any controller exchange and to coordinate performing a controller in a clinical setting.
- Consider the additional factors for controller exchanges when following patients with a pump in the model and serial number subsets identified at higher risk of failure to restart. The factors and subsets are outlined in the Patient Management Recommendations of Medtronic's December 2020, May 2021, and December 2021 and August 2023
- For all patients, follow all instructions provided in Medtronic's Urgent Medical Device Communication Notification Letters and in the Instructions for Use.
- Remind patients of the recommendations in Medtronic's letter, such as always keeping two sources of power connected to the controller, and to investigate and, if possible, correct the cause of any alarms.
- Be aware 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. See Medtronic's October 2022 Urgent Medical Device Correction Letter for more information.
- Be aware of Medtronic's April 2022 Communication which indicates that there is a potential for an internal weld defect that may present similarly to pump thrombosis.
- Treat patients who present with one or more of the signs or symptoms of pump thrombosis for pump thrombosis first.
- Submit all .csv logfiles from the controller to Medtronic, as described in Medtronic's April 2022 Communication, if patients present with any of the following symptoms:
- Grinding sound
- Transient power spikes on the log files and High Watt alarms
- Elevated lactate dehydrogenase
- Low motor speed resulting in low perfusion
- Dizziness or lightheadedness
- Continue to follow instructions provided in the Instructions for Use (IFU) and adhere to current best clinical practices, including strict management of blood pressure and International Normalized Ratio (INR), and the use of system log files to support clinical decision making related to pump performance.
- Inspect the Controller AC and DC Adapters, batteries, and Alarm Adapter for wear and damage during clinical visits. Damaged or worn AC Adapters, DC adapters, batteries, and Alarm Adapters should be taken out of service and replaced with new components.
- Contact your Medtronic Representative for necessary replacement components (for example, controllers, batteries, AC/DC adapters, carrying case), which will continue to be made available by Medtronic.
- Report any adverse events or suspected events experienced with the Medtronic HVAD System through MedWatch as described below.
Resources for Health Care Providers
- Medtronic Patient Information Regarding the HVAD System
- Medtronic Patient Learning Center for the HVAD System
- As a condition of approval, the FDA required the following studies on the HVAD System after it was approved:
- Concordance of Treatment Effect: An Analysis of The Society of Thoracic Surgeons Intermacs Database May 31, 2021 (DOI: https://doi.org/10.1016/j.athoracsur.2021.05.017)
How to Report Problems to FDA
The FDA encourages patients, caregivers, providers, and others to report any adverse events or suspected adverse events experienced with any device, including the Medtronic HVAD System.
Voluntary reports can be submitted through Medwatch, the FDA Safety Information and Adverse Event Reporting program.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this device, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.