Z-0542-2020Class II

myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management...

Name: Z-0542-2020 myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management...
Creator: Endotronix
Published: 2019-09-25
License: https://open.fda.gov/license/

Endotronix, Inc. / initiated 2019-09-25 / Terminated

FDA source

ENDOTRONIX began a recall of myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to... on 2019-09-25. FDA classified it as Class II and gives the reason as "The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0542-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-25
Posted: 2019-11-22
Terminated: 2020-09-21
Recalling firm: Endotronix, Inc.
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.
Product code: OUG Medical Device Data System
Reason for recall: The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
FDA root cause: Other
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.
Quantity in commerce: 58 units
Distribution: TX, IL, GA
Product codes and lots: Model Number 100171-00 Serial Numbers: 352616080403550 352616080468181 352616080592774 352616080559617 352616080399550 352616080560235 352616080460865 352616080561431 352616080561209 352616080472167 352616080559377 352616080560227 352616080468553 352616080560532 352616080559468 352616080561472 352616080460907 352616080559872 352616080560904 352616080558585 352616080560524 352616080559716 352616080560318 352616080691550 352616080690792 352616080687749 352616080684563 352616080687921 352616080675512 352616080677948 352616080691618 352616080674382 352616080683151 352616080678490 352616080682914 352616080679522 352616080672022 352616080679936 352616080605469 352616080596106 352616080613463 352616080680553 352616080678169 352616080670562 352616080679191 352616080682898 352616080678581 352616080673905 352616080692285 352616080690149 352616080603852 352616080692244 352616080677617 352616080687764 352616080690909 352616080677906 352616080604512 352616080608745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0542-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0542-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)