Home › Device types › MXC
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
FDA product code MXC · Class 2 · Cardiovascular
12
Registered devices
11,214
Adverse events
5
Recalls
23
510(k) clearances
Devices with this code
Assert-IQ™ — ST. JUDE MEDICAL, INC.Confirm Rx™ — ST. JUDE MEDICAL, INC.Jot Dx™ — ST. JUDE MEDICAL, INC.Merlin.net™ — ST. JUDE MEDICAL, INC.Confirm Rx™ — ST. JUDE MEDICAL, INC.Assert-IQ™ — ST. JUDE MEDICAL, INC.SJM CONFIRM™ — ST. JUDE MEDICAL, INC.myMerlin™ — ST. JUDE MEDICAL, INC.SJM CONFIRM™ — ST. JUDE MEDICAL, INC.SJM CONFIRM™ — ST. JUDE MEDICAL, INC.Assert-IQ™ — ST. JUDE MEDICAL, INC.myMerlin™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-19 | Abbott | The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. |
| 2018-04-16 | St Jude Medical Inc. | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small n |
| 2018-04-16 | St Jude Medical Inc. | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small n |
| 2018-04-13 | St Jude Medical, Cardiac Rhythm Management Division | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. |
| 2011-03-31 | St Jude Medical CRMD | The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enh |
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