Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
1. HeartMate Touch Communication System Recalled by Thoratec Corp. Due to Due to software and controller systems that results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Thoratec Corp. directly.
Affected Products
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
Quantity: 1,560 systems as of 12/8/2023
Why Was This Recalled?
Due to software and controller systems that results in unexpected pump start or pump stop.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Thoratec Corp.
Thoratec Corp. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report