myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure ...
FDA Device Recall #Z-0542-2020 — Class II — September 25, 2019
Recall Summary
| Recall Number | Z-0542-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 25, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ENDOTRONIX |
| Location | Lisle, IL |
| Product Type | Devices |
| Quantity | 58 units |
Product Description
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.
Reason for Recall
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
Distribution Pattern
TX, IL, GA
Lot / 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
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.