Reported Nov 26, 2025 · Ongoing

Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3…

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 Controller (Standalone)
Model/Catalog Number
- 106531US
- HeartMate 3 Controller
- US
- 106531INT
- HeartMate 3 Controller
- OUS
- 106531LF2
- HeartMate 3 Low Flow 2.0
Controller Software VersionN/A
Product DescriptionThe 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
ComponentYes, HeartMate 3 LVAS

Lot codes and dates: 4 of 4 products
Products covered by this recall
Model / number Barcodes Product as published
— Lot Code: All units of the following models are impacted
106531US 05415067039446 UDI: 05415067039446
106531INT 05415067038982 UDI: 05415067038982
106531LF2 05415067039422 UDI: 05415067039422 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: 35376

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
`106531US`	`05415067039446`	UDI: 05415067039446
`106531INT`	`05415067038982`	UDI: 05415067038982
`106531LF2`	`05415067039422`	UDI: 05415067039422 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.