Medical Device Recall: 11 Volt Li-Ion Backup Battery – May 2026
Abbott is notifying customers of a voluntary recall of the 11V Lithium-Ion Backup Battery that is used as a standalone device, and as part of the HeartMate II™ System Controller, HeartMate 3™ System Controller and Left Ventricular Assist System (LVAS) Kit. Certain 11V Backup Batteries built between 01 January 2026 to 30 April 2026 display a “Replace Backup Battery” warning immediately upon connection to the System Controller. The "Replace Backup Battery" warning is limited to the clinician HeartMate Touch and System Monitor interface display. The functionality of the batteries is unaffected by this issue. Abbott has asked that clinicians review the issue and discontinue the use of impacted batteries currently experiencing the issue described. Replacement of impacted 11V Lithium-Ion Backup Batteries will begin in May 2026.
Check for a Device
Check to see if a specific device is impacted by the HeartMate 11 Volt Li-Ion Backup Battery Recall.
Enter the model and serial number of the HeartMate 3 LVAS kit, controller, or 11V battery. Include uppercase letters and hyphens (-) when inputting numbers that contain them.
Pictures are for reference only to locate the Model/Reference, Serial, or Lot number
Device Lookup Instructions
Please follow the steps below to determine if a device is subject to this recall.
- Enter the entire model/reference and serial numbers for the device, as shown above.
- If the device is subject to this recall, review the recommendations in the customer letter.
- If the device is not subject to this recall, no further action is needed.
These materials are not intended to replace your doctor’s advice or information. For any questions or concerns you may have regarding the medical procedures, devices and/or your personal health, please discuss these with your physician.
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