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.
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.
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.
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.
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.
A Field Safety Notice 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 Ventricular Assist Device (LVAD)
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.
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.
We provided an Important Medical Device Advisory notice to customers regarding incorrect insertion of the HeartMate 3™ modular cable into the HeartMate 3 Left Ventricular Assist System controller.
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 May 28, 2018, we provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 (HM3) 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.
MAT-2105167 v3.0
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MAT-2211958 v1.0
