On November 20, 2018, Abbott provided an Urgent Medical Device Correction notice to customers communicating a voluntary recall of a small number of Confirm Rx™ DM3500 Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app. Please find the below physician communication document for further information.
We notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.
MAT-2010753 v1.0