Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs
Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the device is used to monitor a serious condition (heart failure). The unexpected power-downs represent a risk of harm due to loss of monitoring, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Endotronix is recalling 58 units of the myCordella Patient Kit without ECG. The Cordella System is an at-home heart failure management platform designed to help clinicians monitor the progression of the condition. The recall was initiated after the firm received reports that the myCordella Hubs fully powered themselves down without any interaction from the patient or Endotronix.
The affected units are distributed in Texas, Illinois, and Georgia. The specific model number is 100171-00. Consumers should check their serial numbers against the list provided in the official recall notice to determine if their device is affected.
Because the device is used to monitor heart failure, an unexpected power-down could interrupt the monitoring process. Patients should contact their healthcare provider or Endotronix for instructions on how to proceed with the recall.
The recalled product
- 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.
- Manufacturer
- ENDOTRONIX
- Affected units
- 58
Distribution
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