myCordella Patient Kit without ECG — Class II medical device recall Z-0542-2020
Terminated recall by ENDOTRONIX, reported 2019-12-04, distributed in GA, IL, TX. The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction
| Recall number | Z-0542-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ENDOTRONIX, Lisle, IL, United States |
| Recall initiated | 2019-09-25 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-09-21 |
| Distributed | GA, IL, TX |
| Quantity | 58 units |
| Serial numbers | 352616080399550, 352616080403550, 352616080460865, 352616080460907, 352616080468181, 352616080468553, 352616080472167, 352616080558585, 352616080559377, 352616080559468, 352616080559617, 352616080559716, 352616080559872, 352616080560227, 352616080560235, 352616080560318, 352616080560524, 352616080560532, 352616080560904, 352616080561209, 352616080561431, 352616080561472, 352616080592774, 352616080596106, 352616080603852 and 33 more |
| Model numbers | 100171-00 |
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.
Reason for recall
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0542-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.