Abbott Medical is recalling 130 Merlin@home Transmitters (Model EX1100) and certain MerlinOnDemand Transmitters (Model EX1150). These devices, which are used to remotely monitor data from implanted heart devices, may fail to install essential software updates if power was interrupted during a previous download. This failure prevents the transmitter from sending heart health data to medical providers, which could delay critical healthcare decisions. No injuries or incidents have been reported at this time.
If the transmitter fails to update its software, it cannot monitor a patient's implanted heart device or transmit information to the medical care network. This could prevent doctors from identifying heart rhythm changes or device performance issues in a timely manner.
Inductive (EX1100 Model) read device data and transmitting to the Merlin.net PCN server.
Configured for multiple patient use. Supports remote care in emergency rooms and heart failure clinics.
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Sources: FDA iRES · Raw API Response
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