CardioMEMS HF System Patient Electronics System — Class II medical device recall Z-1219-2023
Ongoing recall by St. Jude Medical, reported 2023-03-15, distributed nationwide. Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM10
| Recall number | Z-1219-2023 |
|---|---|
| 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 | 2023-03-03 |
| 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 | 200 units |
| UPC / GTIN / UDI-DI | 05414734509176 |
| Serial numbers | M140300439, M140300440, M140300441, M140300445, M140300446, M140300447, M140300449, M140300450, M140300451, M140300454, M140300458, M140300459, M140300460, M140300463, M140500480, M140500486, M140800987, M140800988, M140800992, M140800995, M140801002, M140801003, M140801004, M140801007, M140801010 and 175 more |
| Model numbers | CM1010 |
Product
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 failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
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 certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
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-1219-2023. 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.