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Terminated

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.

FDA Recall Z-0542-2020 · Posted None

Recalling FirmENDOTRONIX
Recall StatusTerminated
Product CodeOUG
Date Initiated2019-09-25
Date Terminated2020-09-21
Product Quantity58 units

Reason for Recall

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

Firm Action

The firm disseminated the notices by email on 09/25/2019 to the clinic level. The firm subsequently followed with telephone notices to the user level beginning on 10/16/2019 and posted a notice on their website.

Root Cause

Other

Distribution Pattern

TX, IL, GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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