Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ P…

Recall date

October 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0508-2026

FDA classification

Class II

Brand / firm

Thoratec LLC

Sold / distributed

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahr…

Why it was recalled

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System. Component: Yes, HeartMate II¿ LVAS Implant Kit