August 25, 2022
- Recommendations were added to the Information for Patients and Health Care Providers: HVAD System section about useful life and inspections for HVAD System components.
- The FDA Activities Related to HVAD System table was updated to include the FDA’s Class I recall notice for the June 2022 recall related to the increase in battery electrical faults due to an interaction between the battery software and an internal component.
- 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 newly designed components. Medtronic also identified that the device labeling has been updated with information regarding useful life and inspection of HVAD System components. This update has been added to the Medtronic HeartWare Recalls.
July 28, 2022
Medtronic provided an update on their investigation into the pump weld defect. Health care providers were first notified of the pump weld defect in April 2022. This update has been added below to the Medtronic HeartWare Recalls.
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.
The FDA is committed to providing important updates about the HeartWare device and we will continue to update the public as new information becomes available.
On this page:
- What is the HVAD System?
- Benefits and Risks of HVAD System
- Information for Patients and Health Care Providers: HVAD System
- FDA Activities Related to HVAD System
- Medtronic HeartWare Recalls
- Where to Report Problems FDA Actions: HVAD System
- Additional Resources
Heart failure is a chronic condition that typically worsens over time and can result in end-stage heart failure and death. Patients with end-stage heart failure suffer debilitating shortness of breath and physical exhaustion, painful swelling of the lower extremities, poor circulation (venous stasis) that results in painful wounds (ulcers) that will not heal, and fluid buildup in the lungs (pulmonary edema) and abdomen.
The Medtronic HVAD System is a ventricular assist device used in end-stage heart failure patients who are waiting for a heart transplant. This use is known as bridge-to-transplant. The Medtronic HVAD System may also be used in end-stage heart failure patients who are not eligible or are too sick to receive a heart transplant, and whose symptoms cannot be managed by medications. This use is known as destination therapy, which can extend a patient's life and improve their quality of life. The Medtronic HVAD System helps the heart by supporting the weak left ventricle and providing additional blood flow.
The Medtronic HVAD System includes a pump implanted in the space around the heart (pericardium), a controller that controls the speed and function of the pump, a tube inserted into the heart to drain the blood, and a tube inserted in the aorta for the blood that is being pumped. The controller remains outside the patient's body and is connected to the pump by a flexible tube that passes through the patient's skin. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.
As discussed in the Agency's benefit-risk assessments in 2012 and 2017, and for patients currently supported on the device, the probable benefits of the HVAD System outweigh the probable risks. The benefits of the HVAD system include survival on the device, ability to place the HVAD pump without requiring an abdominal pocket, and ability to place the device in smaller patients when compared to the alternatives. The probable risks include stroke and other neurological events, major infection, bleeding, and right heart failure, all of which could lead to death. The Agency recognizes neurological events, in particular strokes, associated with the HVAD System as the most important probable risk. The current labeling for the HVAD System for patients and health care providers conveys these benefits and risks.
For patients currently implanted with Medtronic's HVAD pump and for providers caring for patients implanted with HVAD, the FDA has the following recommendations:
- Follow all instructions provided in Medtronic's Urgent Medical Device Communication Notification Letters linked below, such as:
- Physicians should remind patients to always keep two sources of power connected to their controller and keep spare batteries with them.
- If a Power Disconnect alarm occurs while a battery is physically connected, that battery should be taken out of service.
- Due to the potential for an internal pump malfunction as described in Medtronic's April 2022 Communication, patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
- Physicians should 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
- Do not clean the pins of the Controller AC Adapter, DC adapter, or Battery connectors. If the connector pins contain any dirt or debris, do not use the device.
- Patients should follow the guidance in the Patient Manual and perform weekly inspections for dirt, grime, and physical damage as described in Section 7.2 Care of Your Controller and Section 7.3 Care of Your Batteries.
- Physicians following patients with a pump in the subset identified at higher risk of failure to restart, discussed in Medtronic's December 2020, May 2021, and December 2021 Communications, should consider the additional factors for controller exchanges outlined in the Patient Management Recommendations of these communications.
- Continue with existing procedures and protocols for the device and contact Medtronic for necessary replacement of peripheral components (for example, controllers, batteries, AC/DC adapters, carrying case), which will continue to be made available by Medtronic.
- 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.
- The 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 of the battery as 500 charge and discharge cycles (this should provide patient support for one year), the AC (wall) power adapter as six months, and the DC (car) power adapter as one year.
- Health care providers should 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.
- Elective removal of an implanted Medtronic HVAD System is not recommended at this time. In general, the risks associated with explant will outweigh the potential benefits. Decisions about removing and/or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient's clinical status and surgical risks.
- Physicians should remind patients to investigate, and if possible, correct the cause of any alarms.
- Report any adverse events or suspected events experienced with the Medtronic HVAD System through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The Medtronic HVAD System was approved, on November 20, 2012, as a bridge to heart transplantation in patients who are at risk of mortality from end-stage left ventricular heart failure. It was also approved for destination therapy on September 27, 2017, in patients for whom a heart transplant is not planned.
Since HeartWare's approval in 2012, the agency has continued to monitor the product's safety and effectiveness by reviewing the medical literature, clinical trial information, postmarket study data and medical device reports submitted to the agency.
A timeline and summary of our most significant activities since June 2021 are provided below.
|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:
Since Medtronic ceased distribution of the HVAD system, the company has voluntarily recalled certain HVAD Systems and/or components, including:
|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.|
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.
|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.
We encourage patients, caregivers, providers and others to report any adverse events or suspected events experienced with the Medtronic HVAD System through the FDA's voluntary reporting program, Medwatch.
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.
- Medtronic Patient Information Regarding the HVAD System
- Post Approval Studies Related to the HVAD System:
- 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)