Voluntary recall and distribution suspension affecting a subset of Medtronic Dual Chamber Pacemakers susceptible to circuit error

Medtronic International Limited would like to inform healthcare professionals of the voluntary recall and distribution suspension of a subset of Medtronic Dual Chamber Pacemakers. These affected devices, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error. The circuit error impacts device functionalities, resulting in issues such as withholding of atrial and ventricular pacing, inability to initiate session with a programmer or CareLink remote monitor, and inability to respond to a magnet. Healthcare professionals are advised to quarantine and return all unused units of the affected medical devices to Medtronic. Medtronic is developing a software update that can be installed into affected devices to correct this issue. As the primary mitigation for patients implanted with an affected device, healthcare professionals are advised to re-program to a non-susceptible pacing mode until this software update is available and installed. Please refer to the letter for details.