Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery — Class II medical device recall Z-2520-2026
Ongoing recall by Thoratec LLC, reported 2026-06-24, distributed nationwide. Due to 11 volt Backup Battery failures.
| Recall number | Z-2520-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2026-05-13 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, ES, JP, NL, PL |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 05415067039880 |
| Model numbers | 106128 |
Product
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 for recall
Due to 11 volt Backup Battery failures.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.