Device recall
Z-1225-2023: CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-1225-2023 |
|---|---|
| Recall event | 91606 |
| Product | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or… |
| Product code | MOM |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P100045 |
| FEI number | 3004936110 |
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