Recall Z-0542-2020 ยท OUG Medical Device Data System
ENDOTRONIX
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
| Date | Sep 25, 2019 |
| Status | Terminated |
| Reason | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| Root cause | Other |
| Action | The firm disseminated the notices by email on 09/25/2019 to the clinic level. The firm subsequently followed with telephone notices to the user level beginning on 10/16/2019 and posted a notice on their website. |
| Quantity | 58 units |
| Distribution | TX, IL, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.