BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0508-2026 · Initiated October 9, 2025

    Recall

    Recall Number
    Z-0508-2026
    Event Number
    97782
    Firm
    Thoratec LLC
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 9, 2025
    Posted
    November 14, 2025
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    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.

    Action

    On 10/09/2025, the firm sent via email an "URGENT MEDICAL DEVICE RECALL (CORRECTION)" Letter to customers informing them that Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. The issue is potentially due to excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller which results in corrosion of the ribbon cable connectors. What Customers should know: When the Backup Battery Fault Alarm is active, this Advisory alarm will appear as a flashing yellow wrench on the user interface and Call Hospital Contact; Backup Battery Fault will appear on the screen, accompanied by a slow beep tone. When in a clinical setting, the HeartMate Touch App will have an active alarm that reads Replace Backup Battery. As a reminder, when this alarm is active and the pump is running and flow is maintained (indicated by the green arrow symbol ), this alarm does not affect the controller or pump functionality. Customers are instructed: -When performing Backup Battery installation or replacement, clinicians should minimize excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller. An example of excessive handling would be using the ribbon cable to hold the weight of the controller. -Remind patients and caregivers to follow the Patient Handbook: If System Controller Backup Battery Fault Alarm is active, patients should first ensure that no other alarms are active, and then they should call their hospital contact as soon as possible for diagnosis and instructions. Patients and caregivers should not immediately attempt to exchange the System Controller without clinical guidance. For questions or further assistance is needed regarding the Backup Battery Alarm after following Instructions for Use, contact Abbott Technical Service at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).

    Distribution

    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, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.

    Quantity

    2424