Device recall
Z-2169-2025: Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the…
FDA device recall · Class II · Medtronic, Inc.
Key facts
| Recall number (Z-number) | Z-2169-2025 |
|---|---|
| Recall event | 97130 |
| Product | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia… |
| Product code | NVZ |
| Recalling firm | Medtronic, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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