Reported Jun 24, 2026 · Ongoing
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A…
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
Is this the product you have?
- Brand NameHeartMate
- Product NameHeartMate 3"
- System Controller Model/Catalog Number106531US
- 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 Left Ventricular System (LVAS) Kits
- Lot codes and dates
- Lot CodeModel
- Number106531US
- UDI/GTIN05415067039446
- Serial Numbers Distributed in USSee Attachment E for serial numbers distributed
- Amount recalled
- 694
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to 11 volt Backup Battery failures.
This product could cause temporary or reversible health problems — stop using it.
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