Device recall
Z-0542-2020: myCordella Patient Kit without ECG, The Cordella System is a comprehensive…
FDA device recall · Class II · ENDOTRONIX
Key facts
| Recall number (Z-number) | Z-0542-2020 |
|---|---|
| Recall event | 83882 |
| 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. |
| Product code | OUG |
| Recalling firm | ENDOTRONIX |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2020 |
| FEI number | 3013900541 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database