[pending] Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128
Pending LLM rewrite. Source: FDA_DEVICE Z-2520-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to 11 volt Backup Battery failures.
The recalled product
- 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
- Manufacturer
- Thoratec LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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