Device recall
Z-1427-2025: CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-1427-2025 |
|---|---|
| Recall event | 96326 |
| Product | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data… |
| 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