FDAFDA · Alimentos y medicamentos·N.º oficial Z-2520-2026
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The 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. Component: Yes, HeartMate 3" System Controller
Publicado el 24 de junio de 2026 · Inicio del retiro: 13 de mayo de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to 11 volt Backup Battery failures.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Thoratec LLC
- Distribuidor
- 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.
- Lote
- Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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