Device recall
Z-2348-2024: St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-2348-2024 |
|---|---|
| Recall event | 94613 |
| Product | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 |
| Product code | DYB |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K061363 |
| FEI number | 2182269 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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