Drug recall
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS…
FDA recall event 96326 · Class II · St. Jude Medical
Key facts
| Event ID | 96326 |
|---|---|
| Recall numbers | Z-1427-2025 |
| Recalling firm | St. Jude Medical |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated… |
| Initiation date | Feb 3, 2025 |
| Report date | Apr 2, 2025 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 3004936110 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: