Recall Z-1220-2019 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Abbott
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, palp
| Date | Apr 25, 2019 (initiated Nov 19, 2018) |
| Status | Terminated |
| Reason | The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 32 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc., Sep 29, 2017 |