Recall Z-0508-2026— Thoratec LLC

Class II FDA medical device recall by Thoratec LLC, initiated 2025-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm..

Recalling firm

Thoratec LLC

Classification

Class II

Status

Ongoing

Initiated

2025-10-09

Firm location

Pleasanton, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.