Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

myCordella Patient Kit without ECG Recalled by ENDOTRONIX Due to The firm have received reports of patients myCordella...

Date: September 25, 2019
Company: ENDOTRONIX
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ENDOTRONIX directly.

Affected Products

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.

Quantity: 58 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: GA, IL, TX

Affected (3 states)Not affected

About ENDOTRONIX

ENDOTRONIX has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report