Class 2 Device Recall Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000)

• Date Initiated by Firm: November 06, 2024
• Date Posted: January 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0987-2025
• Recall Event ID: 95706
• PMA Number: P100045
• Product Classification: System, hemodynamic, implantable - Product Code MOM
• 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.
• Code Information: 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
• FEI Number: 3004936110
• Recalling Firm/ Manufacturer: St. Jude Medical; 387 Technology Cir Nw Ste 500; Atlanta GA 30313-2424
• For Additional Information Contact: Ms. Shelley Lange; 651-756-4091
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 25 systems
• Distribution: U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MOM