Device recall
Z-2334-2018: St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #…
FDA device recall · Class II · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-2334-2018 |
|---|---|
| Recall event | 80244 |
| Product | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as… |
| Product code | MXC |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2021 |
| 510(k) numbers | K163407 |
| FEI number | 2017865 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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