Reported Jun 24, 2026 · Ongoing
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version:…
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 NameHM 11V Li-ion Backup Battery
- ABT Model/Catalog Number106128
- Software VersionN/A
- Product DescriptionThe HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture
- ComponentYes, HeartMate 3" System Controller
- Lot codes and dates
- Lot CodeModel
- Number106128 UDI/GTIN 05415067039880
- Serial Numbers Distributed in USSee Attachment E for serial numbers distributed
- Amount recalled
- 12
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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