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U.S. Department of Health and Human Services

Class 2 Device Recall HeartMate

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 Class 2 Device Recall HeartMatesee related information
Date Initiated by FirmMay 13, 2026
Date PostedJune 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2520-2026
Recall Event ID 99023
PMA NumberP160054 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductBrand 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
Code Information Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
FEI Number 2916596
Recalling Firm/
Manufacturer		 Thoratec LLC
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information ContactSamantha Thai
1-510-2392765
Manufacturer Reason
for Recall		Due to 11 volt Backup Battery failures.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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).
Quantity in Commerce12
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = DSQ
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