Reported Nov 26, 2025 · Ongoing

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US,…

Thoratec LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Thoratec LLC · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270

Brand NameHeartMate
Product NameHeartMate 3 Left Ventricular
System (LVAS) Kits Model/Catalog Number
- 106524US
- HeartMate 3 LVAS KIT
- US
- 106524INT
- HeartMate 3 LVAD KIT
- OUS
- 106524
Software VersionN/A
Product DescriptionThe 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
ComponentNo

Lot codes and dates: 3 of 3 products
Products covered by this recall
Model / number Barcodes Product as published
— Lot Code: All units of the following models are impacted
106524US 00813024013297 UDI: 00813024013297
106524INT 0081302401171 UDI: 0081302401171 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.
Amount recalled: 29059

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Model / number	Barcodes	Product as published
—		Lot Code: All units of the following models are impacted
`106524US`	`00813024013297`	UDI: 00813024013297
`106524INT`	`0081302401171`	UDI: 0081302401171 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.