Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US
- Recall date
- 2026-06-24
- Brand
- Thoratec LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to 11 volt Backup Battery failures.
Recommended action
What to do
694
Product description
Due to 11 volt Backup Battery failures.