Medical Device Recall: HeartMate Mobile Power Unit (MPU) Performance Issues — March 2025
Abbott is notifying hospital customers of occurrences where certain units of the HeartMate™ Mobile Power Unit (MPU), as used with HeartMate 3™ Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS, have experienced sudden, unexpected performance issues such as not turning on, unprompted shut down, or suddenly turning off and restarting, with the System Controller indicating a Yellow Wrench alarm or “No External Power” alarm. These issues have been linked to an electrical component in certain MPUs distributed between April 2024 and February 2025. Abbott has asked that clinicians review the issue with impacted patients and provide a patient letter as applicable and discontinue the use of impacted units currently experiencing the performance issues described. Replacement of impacted MPU devices will begin in June 2025 or earlier when sufficient inventory is available.
Medical Device Correction: HeartMate 3 System Controller — July 2024
Abbott is notifying customers of a potential issue identified with HeartMate 3™ System Controllers. Abbott has identified that there is a potential for the specific controllers to have a lifted User Interface (UI) membrane that when present, is observed along the edge of the controller housing, near the Display Button. The product is not being removed from the field. This letter contains important information and recommendations regarding this issue.
Product Information Letter: HeartMate 3 Electrostatic Discharge Awareness — July 2024
Abbott notified customers about air fluidized specialty beds as a potential source of static electricity and the possible impact on functionality of the HeartMate 3™ LVAS. This letter enhances information already in the Instructions for Use. Alternatives to air fluidized specialty beds should be considered when using the HeartMate 3 LVAS.
Medical Device Correction: HeartMate System Monitor – May 2024
Abbott notified customers regarding complaints received for the HeartMate™ System Monitor where the screen may display atypical behavior. The distributed letter provides recommendations and guidance to follow if screen issues are observed. The System Monitor is not being removed from the field and does not need to be returned to Abbott.
Medical Device Correction: HeartMate 3 LVAS Kits – March 2024
Abbott is notifying customers of complaints of blood leaking out of the left ventricle or air entering the left ventricle or LVAD at the seal interface between the HeartMate 3™ LVAS inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. The letter contains important information when observing blood leaking from the LVAD or air passing into the left ventricle and LVAD. There is no need to return any product to Abbott.
Beginning in January 2025, Abbott is notifying customers of important updates to the communication sent in 2024 within the attached letter. This update is related to a design solution intended to mitigate the occurrence of this issue.
Medical Device Correction: HeartMate LVAS Kits and Outflow Grafts – February 2024
Abbott is notifying customers of a planned update to our Instructions for Use associated with observed outflow graft deformation known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS. The letter contains important information on how to recognize EOGO and recommended steps to diagnose EOGO. There is no need to return any product to Abbott.
Medical Device Correction: HeartMate Touch Communication System – January 2024
An urgent Medical Device Correction was issued on January 3, 2024, indicating that the HeartMate Touch™ Communication System Application Ver. 1.0.32 could result in an unintentional start/stop of the HeartMate 3 Left Ventricle Asist Device (LVAD)
Medical Device Correction: HeartMate 3 LVAS Kits and Apical Coring Knife - August 2023
Abbott is notifying customers of a finding with the HeartMate Apical Coring Knife provided with the HeartMate 3 Left Ventricular Assist System (LVAS) kits and distributed separately.
The specific impacted serial numbers are listed on the links below. Please review Appendix A as of August 2023, Appendix A Expanded Scope as of September 2023, and Appendix A Expanded Scope as of October 2023 for the specific serial numbers within the scope of this notification.
Abbott is notifying customers about a single reported event where the HeartMate Touch™ Communication System connected to an unintended LVAS. This communication is to bring awareness and emphasize existing Instructions for Use.
An urgent Medical Device Correction was issued on October 22, 2021, communicating that the HeartMate Touch™ Communication System Application is unexpectedly closing or failing to open.
On December 2, 2019, Abbott provided an Urgent Medical Device Recall notice to customers regarding inference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3™ Left Ventricular Assist System.
On March 30, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely.
On March 7, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover.
On October 17, 2018, Abbott provided an update to physicians on the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System. Abbott has received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice.
On May 22, 2018, FDA classified this medical device advisory as a Class I Recall. Abbott provided a Frequently Asked Questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.
On May 21, 2018, Abbott provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
On April 5, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
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