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HeartMate 3 recallZ-2519-2026 · Thoratec LLC · initiated May 13, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Thoratec LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to 11 volt Backup Battery failures.

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number
Z-2519-2026
Status
Open, Classified
Initiated by the company
May 13, 2026
Posted by the FDA
Jun 18, 2026
Recalling firm
Thoratec LLC
Quantity
694
Product code
DSQ
FDA submissions
P160054
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.

Product description

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

Code information (models, lots, serial numbers)

Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

24 devices cleared under P160054 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99023).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page