Thoratec LLC is recalling approximately 1,661 HeartMate Mobile Power Units (MPU) used with the HeartMate 3 and HeartMate II heart pump systems. An internal electrical component may fail, which can cause the power unit to shut down unexpectedly, restart, or fail to turn on entirely. Affected units were distributed worldwide between April 2024 and February 2025.
If the power unit fails, the system controller will sound a 'Yellow Wrench' or 'No External Power' alarm and provides only 15 minutes of backup power. If the patient does not immediately switch to rechargeable batteries, the heart pump will lose power and stop working, which is a life-threatening emergency.
Used with HeartMate 3 and HeartMate II Left Ventricular Assist Systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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