Endotronix recalls myCordella Patient Kit without ECG due to reports of hubs powering down unexpectedly. Affected units have specific serial numbers. Users should stop using immediately.
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
Endotronix is recalling its myCordella Patient Kit without ECG because it has been reported to shut down unexpectedly without patient or company interaction. This could disrupt heart failure monitoring and requires immediate action.
The hubs in the myCordella Patient Kit can power down unexpectedly without any input from the patient or Endotronix. This may cause interruptions in heart failure monitoring, potentially leading to missed health data and treatment adjustments.
Patients using the myCordella Patient Kit without ECG for home heart failure management are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your myCordella Patient Kit has the model number 100171-00 and the listed serial numbers (e.g., 352616080403550).
Discontinue use of the myCordella Patient Kit without ECG as it may shut down unexpectedly.
The model number is 100171-00.
The affected serial numbers are listed in the recall: 352616080403550, 352616080468181, and others (see full list in the recall notice).
Endotronix has received reports that the hubs in the myCordella Patient Kit can power down unexpectedly without patient or company interaction.
We’ve drafted a message you can send Endotronix to request your refund or repair — edit it as you like.
Subject: Recall Z-0542-2020 — Endotronix Endotronix Hello, I own a Endotronix that is covered by recall Z-0542-2020 from Endotronix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
