Merlin — Class II medical device recall Z-0987-2025
Ongoing recall by St. Jude Medical, reported 2025-01-29, distributed in CA, CT, GA, IL, MI, MN, NC, NJ…. Due to a data migration from on-premises server to the cloud environment, some customers reported that they we
| Recall number | Z-0987-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atlanta, GA, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, WA |
| Quantity | 25 systems |
| UPC / GTIN / UDI-DI | 05414734510035 |
| Serial numbers | M220200018, M220200028, M220300070, M220300173, M220300186, M220700135, M220900036, M220900045, M220900050, M220900052, M220900089, M220900109, M221100017, M221100020, M221100043, M221100060, M230500037, M230500038, M230900026, M230900037, M231100022, M240100031, M240100086, M240500086, M240500088 |
| Model numbers | CM3100, MN6000 |
Product
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) 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 a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit 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-0987-2025. 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.