[pending] Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi
Pending LLM rewrite. Source: FDA_DEVICE Z-2291-2025.
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 misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
The recalled product
- Product
- Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
- Manufacturer
- Thoratec LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: US Model No 107754
- UDI-DI 05415067038234 Serial Numbers
- see Attachment F.
Distribution
Distributed nationwide across the United States.
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