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-2518-2026
Brand
Thoratec
Classification
Class II
Units affected
4
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

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: 106524US UDI/GTIN 05415067039323 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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