Recall Z-0542-2020— ENDOTRONIX
Class II · Terminated
Class II FDA medical device recall by ENDOTRONIX, initiated 2019-09-25, terminated 2020-09-21. FDA's recall record names no specific 510(k) clearance for this event. 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: The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix..
- Recalling firm
- ENDOTRONIX
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-25
- Terminated
- 2020-09-21
- Firm location
- Lisle, IL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.