Drug recall
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides…
FDA recall event 91606 · Class II · St. Jude Medical
Key facts
| Event ID | 91606 |
|---|---|
| Recall numbers | Z-1223-2023, Z-1224-2023, Z-1225-2023 |
| Recalling firm | St. Jude Medical |
| Product type | Devices |
| Products | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart…, CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level… |
| Initiation date | Feb 7, 2023 |
| Report date | Mar 15, 2023 |
| 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: