Class II — ENDOTRONIX
| Recalling firm | Endotronix |
|---|---|
| Registered facility | ENDOTRONIX (Naperville) (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| Product | 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. |
| Quantity | 58 units |
| Distribution | TX, IL, GA |
| Initiated | 2019-09-25 |
| Classified | 2019-11-22 |
| Terminated | 2020-09-21 |
| Recall number | Z-0542-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ENDOTRONIX (Z-0542-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83882/
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