FDASeptember 25, 2019device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
What to do
FDA enforcement status: Terminated
Brands named
endotronix
Recall history
No related federal recalls on record for this brand yet.
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