Drug recall
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides…
FDA recall event 91610 · Class II · St. Jude Medical
Key facts
| Event ID | 91610 |
|---|---|
| Recall numbers | Z-1218-2023, Z-1219-2023, Z-1220-2023, Z-1221-2023 |
| Recalling firm | St. Jude Medical |
| Product type | Devices |
| Products | CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart…, CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart…, CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart…, CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, 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 | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed… |
| 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: