02

Feb

2024

FDA Recall: Software Errors Resulting in Unexpected Pump Start/Stop

0

Company: Thoratec Corp.
Date of Enforcement Report: 2/2/2024
Class I

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

Recall Number:

Z-0842-2024

REASON:

Due to software and controller systems that results in unexpected pump start or pump stop.

RECALLING FIRM/MANUFACTURER:

Thoratec Corp.

VOLUME OF PRODUCT IN COMMERCE:

1,560 systems as of 12/8/2023

DISTRIBUTION:

Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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