FDA DeviceClass IINotable

FDA Recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US

Date: 2026-06-24
Brand: Thoratec LLC
Category: Medical Device
FDA Class: Class II

Description

Due to 11 volt Backup Battery failures.

Hazard

Due to 11 volt Backup Battery failures.

Remedy

694

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