Device recall
Z-0808-2020: Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable…
FDA device recall · Class II · St Jude Medical, Cardiac Rhythm Management Division
Key facts
| Recall number (Z-number) | Z-0808-2020 |
|---|---|
| Recall event | 84453 |
| Product | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to… |
| Product code | MXC |
| Recalling firm | St Jude Medical, Cardiac Rhythm Management Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 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