FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Medical device · Recalled June 24, 2026

Brand Name recall — Thoratec LLC

Hazard: Due to 11 volt Backup Battery failures.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2519-2026
Brand
Thoratec
Classification
Class II
Units affected
694
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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

Affected products

Companies & origin

Recalling firm location
Pleasanton, CA, United States
Firm address
6035 Stoneridge Dr, 94588-3270

Identifying details (verbatim from the notice)

Product codes / lots
Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
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.
Firm notified the public via
Letter
FDA event ID
99023
Recall initiated
May 13, 2026
FDA classified
June 18, 2026
FDA report date
June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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