Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N
Summary
The FDA issued a Class II for Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catal by Thoratec LLC. Reason: Due to 11 volt Backup Battery failures..
Details
Source
Device Recall
External ID
Z-2519-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
Quantity Affected: 694
Reason for Recall
Due to 11 volt Backup Battery failures.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-13
Company
Pleasanton, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Thoratec LLC has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thoratec LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thoratec LLC have FDA actions?
Thoratec LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2519-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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