Regulator FDA — Thoratec LLC device-recallcardiac-rehabilitationpatient-safety

FDA recall: Brand Name: HeartMate

FDA — Thoratec LLC · 2025-10-09 · By Thoratec LLC

The FDA has issued an open recall for the HeartMate 3 Left Ventricular Assist System (LVAS) kits due to a potential corrosion problem in the Backup Battery cable connector that could trigger a Backup Battery Fault Alarm. The HeartMate 3 is an implantable device used to support cardiac function in patients with advanced heart failure by taking over some or all of the left ventricle's pumping workload. Physical therapists treating patients with ventricular assist devices should be aware of this safety concern when monitoring device-dependent patients during rehabilitation.

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