PlainRecalls
FDA Devices Critical Class I Ongoing

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 wit

Reported: February 14, 2024 Initiated: January 3, 2024 #Z-0842-2024

Product Description

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 for Recall

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

Details

Recalling Firm
Thoratec Corp.
Units Affected
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.
Location
Pleasanton, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Thoratec Corp.. Units affected: 1,560 systems as of 12/8/2023.
Why was this product recalled? ▼
Due to software and controller systems that results in unexpected pump start or pump stop.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0842-2024.

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