August 25, 2022 — The U.S. Food and Drug Administration (FDA) issued a statement that Medtronic, Inc. is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs, batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.
If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death.
Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Recalled Product
- Product Name: Medtronic HVAD Batteries
- Model Numbers: 1650DE
- Devices Being Recalled: 23,372
- Dates distributed: January 1, 2009 to present
- Date Initiated by Firm: June 28, 2022
Device Use
The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned. The system operates using power from either AC or DC electricity or batteries.
Reason for Recall
Medtronic, Inc. is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.
If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death.
Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.
Who May Be Affected
- Health care providers who manage the care of patients with an implanted Heartware HVAD System
- Patients who have the Heartware HVAD System implanted
Information for Patients and Health Care Providers: HVAD System
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.
Background
The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned. The system operates using power from either AC or DC electricity or batteries.
What to Do
On June 28, 2022, Medtronic issued an Urgent Medical Device Correction letter to affected customers about this issue as well as a previous battery recall. This letter also asked customers to take the following actions to help address the battery electrical fault:
- Keep two sources of power connected to their controller and have fully charged spare batteries available at all times.
- Acknowledge and report alarms.
- Follow the Instructions for Use (IFU) for proper power source management.
- Be vigilant if the battery indicator lights do not decrease over time while the battery is in use.
- If the lights do not decrease over time while the battery is in use, this could be a sign of battery electrical fault and the battery should not be used.
- Pay attention to the battery indicator lights.
- Do not use a battery if the indicator lights do not light up.
- Check to make sure:
- Battery capacity display lights up
- Battery indicator on the controller lights up
- Battery charger status light does not flash red or yellow after connecting the battery
The Letter provided additional instructions for customers including:
- Complete a customer confirmation form and return it to [email protected].
- Share the letter with all those who need to be aware within the organization and with any organization where patients have been transferred.
Medtronic HeartWare Recalls
Since Medtronic ceased distribution of the HVAD system, the company has voluntarily recalled certain HVAD Systems and/or components, including:
| Date | Description |
|---|---|
| August 2022 | Medtronic issued an Urgent Medical Device CorrectionExternal Link Disclaimer 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 2021External Link Disclaimer. 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 CorrectionExternal Link Disclaimer 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 CorrectionExternal Link Disclaimer to inform health care providers and patients about two issues with the HVAD Battery.
|
| June 2022 | Medtronic issued an Urgent Medical Device CorrectionExternal Link Disclaimer 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 CorrectionExternal Link Disclaimer 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 CorrectionExternal Link Disclaimer 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 CommunicationExternal Link Disclaimer 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 CommunicationExternal Link Disclaimer 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 CommunicationExternal Link Disclaimer for this issue in December 2020. In May 2021, Medtronic also issued an Urgent Medical Device CommunicationExternal Link Disclaimer 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 CommunicationExternal Link Disclaimer 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 CommunicationExternal Link Disclaimer to inform health care providers that Medtronic has stopped the distribution and sale of its HVAD System. |
Conact Information
- Health care providers with questions about this recall should contact their local Medtronic Representative.
- Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday - Friday, 8 a.m. to 5 p.m. Central time).
October 02, 2024 
