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.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.