Lower riskMedical device recall · FDA · Published May 13, 2026
HeartMate 3 System Controller Recall: Backup Battery Failures Risk
Thoratec recalls HeartMate 3 System Controller (model 106531US) due to potential 11-volt backup battery failures. Affected users should contact for remedy.
“HeartMate 3 System Controller Recall: Backup Battery Failures Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49174-heartmate-3-system-controller-recall-backup-battery-failures-risk. Based on FDA recall #Z-2519-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2519-2026%22&limit=1).
The FDA announced on May 13, 2026, that Thoratec LLC is recalling the HeartMate 3 System Controller due to potential 11 volt backup battery failures. The agency issued recall number Z-2519-2026 for the device distributed worldwide.
How to tell if you have it
HeartMate 3 System Controller
Model/Catalog Number: 106531US
UPC: 05415067039446
The hazard
The recall is due to 11 volt backup battery failures. The HeartMate 3 System Controller acts as the central power and communication hub for the HeartMate 3 LVAS.
Context
GovInfoNow's records show Thoratec LLC has five other recalls on record since June 25, 2024. Recent Thoratec recalls include a CentriMag Blood Pump recall on Oct. 10, 2025, for pumps that may not securely lock into the motor, and a HeartMate II LVAS Implant Kit recall on Oct. 9, 2025, regarding backup battery fault alarms. Other recent recalls of similar products include the Ventec VOCSN+Pro Ventilator recall (May 8, 2026) for backup alarm failures, the Philips Allura Xper FD10C Medical System recall (Dec. 15, 2025) for electrical short-circuit risks, and the Philips Cardiac Workstation 7000 recall (July 1, 2026) for inaccurate heart rate data.
How to tell if you have this one
Check for the model number 106531US on the HeartMate 3 System Controller. The product was sold in the US with specific serial numbers listed in Attachment E.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-2518-2026
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No; Lot Code: Model Number: 106524US UDI/GTIN 05415067039323 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
4
Z-2519-2026
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits; Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
694
Z-2520-2026
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; Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
12
Based on the official FDA remedy
What to do — step by step
Check Controller Model
Identify the model number on the controller, which should be 106531US for affected units.
Contact Manufacturer
Reach out to Thoracec LLC for further instructions on the recall remedy.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2519-2026 (May 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2519-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.