CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System… — Class II medical device recall Z-0989-2025
Ongoing recall by St. Jude Medical, reported 2025-01-29, distributed nationwide. As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an
| Recall number | Z-0989-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atlanta, GA, United States |
| Recall initiated | 2024-10-05 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 431 units |
| UPC / GTIN / UDI-DI | 05414734510035 |
| Model numbers | CM3000, MN6000 |
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
Reason for recall
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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-0989-2025. 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.