CardioMEMS HF System PA Sensor and Delivery System — Class II medical device recall Z-1223-2023
Ongoing recall by St. Jude Medical, reported 2023-03-15, distributed nationwide. Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevatio
| Recall number | Z-1223-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atlanta, GA, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-06 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CO, CZ, DE, DK, ES, FI, FR, GB, IE, IT, KW, NL, PT, SA, SE |
| Quantity | 36,875 units |
| UPC / GTIN / UDI-DI | 05414734509237 |
| Serial numbers | H24Y92, H24YB8, H24YJY, H24YSK, H24YY9, H24YZG, H24Z3B, H24Z8S, H24ZEE, H24ZF7, H24ZHH, H24ZMN, H24ZTV, H24ZVP, H24ZWL, K24YFW, K25YCE, K25YEY, K25YKN, K25Z4K, K26WLC, K26WN6, K26WT4, K26WVE, K26WY3 and 475 more |
| Model numbers | CM2000 |
Product
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 failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
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; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1223-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.