Device recall
Z-2127-2025: Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number…
FDA device recall · Class II · Medtronic, Inc.
Key facts
| Recall number (Z-number) | Z-2127-2025 |
|---|---|
| Recall event | 97125 |
| Product | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model… |
| Product code | KRG |
| Recalling firm | Medtronic, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P010015, P010031, P150033, P890003, P980016, P980035 |
| 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