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RecallWatchMedical Device Safety
Class IIOngoingZ-0987-2025

St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Wh…

St. Jude MedicalAtlanta, GA, United StatesReported Jan 29, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeModel Number
    25 affected lots
    M220200018M220200028M220300070M220300173M220300186M220700135M220900036M220900045
    +17 moreM220900050M220900052M220900089M220900109M221100017M221100020M221100043M221100060M230500037M230500038M230900026M230900037M231100022M240100031M240100086M240500086M240500088

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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