HeartMate Touch Communication System recalled for software pump operation defects
Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. The defect affects a critical life-support device where unexpected pump operation could result in serious patient harm, although no illnesses or deaths are reported in the source text.
Plain-English summary
Thoratec Corp. is recalling the HeartMate Touch Communication System, a software and hardware system used to program, monitor, and manage Left Ventricular Assist Devices (LVADs) in patients dependent on these life-support devices. The recall affects three model variants: HMT1100, HMT1100-R (rental), and HMT1150, with approximately 1,560 systems affected as of December 8, 2023.
The recall is due to software and controller system defects that can cause unexpected pump starts or stops. These malfunctions could compromise the safe operation of the connected LVAD, creating potential risks for patients who rely on continuous device function for heart support.
The affected systems have been distributed worldwide, including throughout the United States and in 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 the United Arab Emirates.
The recalled product
- 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
- Manufacturer
- Thoratec Corp.
- Hazard
- pump-malfunction
- software-defect
Distribution
Distributed nationwide across the United States.
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