Z-2519-2026Class II

Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software...

Name: Z-2519-2026 Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software...
Creator: Thoratec LLC
Published: 2026-05-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-05-13 / Open, Classified

FDA source

Thoratec LLC began a recall of Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3"... on 2026-05-13. FDA classified it as Class II and gives the reason as "Due to 11 volt Backup Battery failures". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2519-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-13
Posted: 2026-06-18
Recalling firm: Abbott Medical
Product: 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
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Due to 11 volt Backup Battery failures.
FDA root cause: Under Investigation by firm
Action: 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).
Quantity in commerce: 694
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 codes and lots: Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2519-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2518-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18
Z-2519-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18
Z-2520-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)