Overview
A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.
This specific medical device recall involving Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A is classified as Class II, and was reported on June 24, 2026 by Thoratec LLC.
The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.
What Happened
Thoratec LLC initiated action on Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A on June 24, 2026 after identifying a device performance or malfunction concern. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.
The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.
Affected Products
The product identified in this notice is Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A, manufactured or distributed by Thoratec LLC.
FDA records describe the affected product as: 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 Power Module, the Mobile Power…
Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.; a reported quantity of 694; distribution reported as Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA,…; origin or reporting location of Pleasanton, CA, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.