Device recall
Z-0989-2025: CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-0989-2025 |
|---|---|
| Recall event | 95602 |
| Product | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital… |
| 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