Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Ho

FDA device recall Z-0987-2025 · posted 2025-01-17 · Open, Classified

Recall details

Recalling firm

St. Jude Medical

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MOM

Quantity affected

25 systems

Distribution

U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A

Date initiated

2024-11-06

Date posted

2025-01-17

Location

Atlanta, GA