[pending] Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US
Pending LLM rewrite. Source: FDA_DEVICE Z-2519-2026.
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: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the P
- Manufacturer
- Thoratec LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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