Recall Z-2102-2021 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Reveal LINQ LNQ11 / PA96000
| Date | Jun 1, 2021 |
| Status | Open, Classified |
| Reason | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians. |
| Root cause | Software design |
| Action | The firm began notifying their consignees on 06/02/2021 by letter. The letter explained the issue, provided patient management recommendations, and reported that a software update was anticipated in late 2021. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043. |
| Quantity | 666210 devices |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162855 | Reveal LINQ Medtronic, Inc., Feb 23, 2017 |