FDA Medical Device Recalls (openFDA)
ENDOTRONIX: 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.
- Recall number
- Z-0542-2020
- Recalling firm
- ENDOTRONIX
- 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.
- Status
- Terminated
- Initiated
- 2019-09-25
- Posted
- not on file
- Terminated
- 2020-09-21
- Reason
- The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
- 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
- 58 units
- Distribution
- TX, IL, GA
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- Firm FEI
- 3013900541
- Firm city
- Lisle
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28