FDA recall Z-0542-2020

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 for recall

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

Distribution

TX, IL, GA

Key facts

Status

Terminated

Initiation date

2019-09-25

Report date

2019-12-04

Termination date

2020-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lisle, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2020