Device recall
Z-1220-2019: St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile…
FDA device recall · Class II · Abbott
Key facts
| Recall number (Z-number) | Z-1220-2019 |
|---|---|
| Recall event | 82536 |
| Product | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring… |
| Product code | MXC |
| Recalling firm | Abbott |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 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