Merlin.net PCN Heart Failure Web App (St. Jude) – Data Migration Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
St. Jude Medical
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Merlin.net Patient Care Network Heart Failure Web Application Model Number: MN6000 UDI-DI code: 05414734510035 CardioMEMS Hospital system Model: CM3100 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
St. Jude Medical is recalling Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces due to Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Recommended Action
Per FDA guidance
On 11/06/2024, the firm sent an "URGENT: MEDICAL DEVICES CORRECTION", to customers to inform them that on September 30, 2024, the Merlin.net PCN HF Portal (MN6000) was migrated to the cloud database and following the migration, some customers reported that their Hospital Systems were unable to transmit to the Merlin.net PCN. User Action Requested: Abbott requests that clinicians take the following actions: The Impacted CM3100 Hospital System devices at your facility is/are listed in the enclosed Appendix. o For a Hospital System marked SESSIONS SENT no further correction is needed. o Hospital Systems marked UNSENT SESSIONS should be turned on to send unsent sessions: If your Hospital System has connectivity, it will immediately attempt to send after boot-up. A spinning icon will appear to indicate that transmission is in progress. If you see a button on the home screen showing X Unsent Sessions select the button and follow the prompts to send. If you are unable to send sessions, contact Abbott Remote Care Technical Support (RCTS) for assistance. Distribute this notice to appropriate personnel within your institution. Complete the included acknowledgment form and return it to Abbott. NOTE: Hospital Systems that were not used between September 30, 2024, and October 15, 2024, are not impacted. any questions about this notice or potential patient impact, please contact your Abbott representative or Remote Care Technical Support at 1-844-MYCMEMS (692-6367) Monday Friday, 5AM PST 5PM PST.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, GA, IL, MI, MN, NJ, NY, NC, OR, PA, TX, WA
Page updated: Jan 10, 2026