Thoratec Recalls HeartMate Touch Communication

Thoratec has recalled (Class 1) its HeartMate Touch Communication System due to software design issues. The Touch application is intended to be loaded onto a tablet to provide a user interface with hardware/software platforms for supporting left ventricular assist device (LVAD) patients, according to Thoratec. The application also introduces features that enable users to set up pairing and connection with the existing HeartMate 3 Left Ventricular Assist System via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller, the company says.

Earlier this year, the company says it sent an urgent medical device correction letter that told customers it had received complaints for the HeartMate Touch Communication System application version 1.0.32 due to unintentional start/stop of the HeartMate 3 Left Ventricle Assist Device. The letter also provided recommendations for preventing an unintentional LVAD start/stop from occurring.