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 Merlin.net 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.
This recall has been terminated (originally issued April 25, 2019).
- Company
- Abbott
- Recall Initiated
- November 19, 2018
- Posted
- April 25, 2019
- Terminated
- April 28, 2021
- Recall Number
- Z-1220-2019
- Quantity
- 32 devices
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Distribution
US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
Lot / Code Info
Serial numbers 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 9224490, 9224503, 9224525, 9224529, 9225190, 9225203, 9225205, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242219, 9242225, 9242231, and 9256057.
Root Cause
Software design
Action Taken
Abbott sent an Important Medical Device Correction letter dated November 20, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Should you have questions about this issue, contact your local Abbott Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S.), 8:30am - 5:30pm Central Time Monday thru Friday.