CardioMEMS Heart Failure — Class II medical device recall Z-1427-2025
Ongoing recall by St. Jude Medical, reported 2025-04-02, distributed nationwide. Due to issues associated with data migration of patient information and results to a Cloud service, the firm h
| Recall number | Z-1427-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atlanta, GA, United States |
| Recall initiated | 2025-02-03 |
| Classified | 2025-03-21 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 193 devices |
| UPC / GTIN / UDI-DI | 05414734510035 |
| Serial numbers | M220200009, M220200013, M220200022, M220200045, M220300001, M220300003, M220300005, M220300007, M220300010, M220300016, M220300019, M220300029, M220300031, M220300034, M220300036, M220300041, M220300045, M220300047, M220300048, M220300061, M220300069, M220300076, M220300078, M220300079, M220300081 and 166 more |
| Model numbers | CM3100, CM4000, MN6000 |
Product
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Reason for recall
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
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-1427-2025. 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.