medical Class III Updated 2024-12-04

Abbott Medical recalls Merlin@home with the MerlinOnDemand capability Transmitter R

Recalled Product

Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN


Hazard / Issue

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
View official government recall

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