Recall Z-0808-2020 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confir
| Date | Apr 13, 2018 |
| Status | Terminated |
| Reason | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. |
| Root cause | Process control |
| Action | No notification was issued for the memory corruption problem. |
| Quantity | 2,906 impacted ICMs |
| Distribution | Worldwide distribution - US Nationwide. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jord |
| 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 |