Device recall
Z-1605-2016: Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Recall number (Z-number) | Z-1605-2016 |
|---|---|
| Recall event | 73780 |
| Product | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing… |
| Product code | NVZ |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2017 |
| PMA numbers | P890003, P890003S102, P890003S228 |
| FEI number | 2182208 |
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