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ENDOTRONIX recalls myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform tha
Recalled December 4, 2019 · FDA recall Z-0542-2020 · ENDOTRONIX
Hazard
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. · FDA Class II
Units
58 units
Sold at
TX, IL, GA
Description
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.
Manufacturer(s)
ENDOTRONIX
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →