Device recall
Z-0399-2018: MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Recall number (Z-number) | Z-0399-2018 |
|---|---|
| Recall event | 77964 |
| Product | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to… |
| Product code | NVZ |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2024 |
| PMA numbers | P890003 |
| 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