CardioMEMS Patient Electronic System — Class II medical device recall Z-0218-2024
Ongoing recall by St. Jude Medical, reported 2023-11-15, distributed nationwide. Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
| Recall number | Z-0218-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atlanta, GA, United States |
| Recall initiated | 2023-10-04 |
| Classified | 2023-11-03 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CZ, DE, DK, ES, FR, GB, IE, IT, KW, NL, PT, SA, SE |
| Quantity | 36,153 units |
| UPC / GTIN / UDI-DI | 05414734509800 |
| Serial numbers | P150800220, P150800222, P150800226, P150800240, P150800242, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800273, P150800277, P150900313, P150900315, P150900318, P150900319, P150900322, P150900333, P150900334, P150900335 and 475 more |
| Model numbers | CM1100 |
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Reason for recall
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
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-0218-2024. 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.