Quick Facts at a Glance
- Recall Date
- May 13, 2026
- Hazard Level
- HIGH
- Brand
- Thoratec
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Thoratec
- Model numbers
- Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 13, 2026
Reported by FDA DEVICE
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to 11 volt Backup Battery failures.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Thoratec LLC or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Reason: Due to 11 volt Backup Battery failures.. Classification: Class II. Quantity: 12. Distribution: 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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