Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller
Recall
- Recall Number
- Z-2520-2026
- Event Number
- 99023
- Firm
- Thoratec LLC
- FEI Number
- 2916596
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 13, 2026
- Posted
- June 18, 2026
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270
Description
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller
Due to 11 volt Backup Battery failures.
On 05/13/2026, the firm sent email an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that As of April 27, 2026, Abbott received twenty-four (24) complaints where an advisory warning, Replace Backup Battery, was triggered once certain 11V Backup Batteries were connected to the System Controller. This warning is displayed as a yellow banner on the HeartMate Touch Monitor and System Monitor. This advisory alert is only visible when using HeartMate Touch or the System Monitor in the clinic, it is not visible to the patient. Customers are instructed to: 1. Read this notification thoroughly, complete and sign the form included with this letter, acknowledging that you received and understand this information, and that you will communicate this information to those relevant in your facility. Once complete, return the acknowledgement form to Abbott. 2. Use the online lookup tool (https://www.cardiovascular.abbott/us/en/hcp/product-advisories/heartmatebatteries-2026.html) to confirm if a 11V Lithium-Ion battery at your site is an impacted one. Figure 3 shows an instruction on how to locate the serial numbers of the impacted batteries. 3. Once the impacted batteries are identified, do not use them. 4. Beginning May 15, 2026, a separate email will be sent to your site confirming shipment of replacement batteries. This email will include return shipping labels and a device retrieval form, along with detailed instructions for returning the affected batteries. For Questions - contact your Abbott representative or Abbott Technical Support at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
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