Lisle, IL, United States
ENDOTRONIX recalls
1 recall recorded since 2018, most recently on 25 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 September 2019
- Terminated
- 21 September 2020
- Reason
- The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
- Distribution
- TX, IL, GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0542-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.