Recall Z-0842-2024— Thoratec Corp.

Class I FDA medical device recall by Thoratec Corp., initiated 2024-01-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Due to software and controller systems that results in unexpected pump start or pump stop..

Recalling firm

Thoratec Corp.

Classification

Class I

Status

Ongoing

Initiated

2024-01-03

Firm location

Pleasanton, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.