ENDOTRONIX recalls myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform th…

Recall date

September 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0542-2020

FDA classification

Class II

Brand / firm

ENDOTRONIX

Sold / distributed

TX, IL, GA

Why it was recalled

The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.