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U.S. Department of Health and Human Services

Class 2 Device Recall myCordella

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  Class 2 Device Recall myCordella see related information
Date Initiated by Firm September 25, 2019
Create Date November 22, 2019
Recall Status1 Terminated 3 on September 21, 2020
Recall Number Z-0542-2020
Recall Event ID 83882
Product Classification Medical device data system - Product Code OUG
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.
Code Information 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  
Recalling Firm/
Manufacturer		 ENDOTRONIX
815 Ogden Ave
Lisle IL 60532-1337
Manufacturer Reason
for Recall		 The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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