Recall – Insertable Cardiac Monitor unable to pair with mobile app

Company: St Jude Medical Inc.
Date of Enforcement Report: 5/1/2019
Class II:


St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Recall Number: Z-1220-2019


The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.


St Jude Medical Inc. on 11/19/2018. Voluntary: Firm Initiated recall is ongoing.

32 devices


US Nationwide

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