Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model Recalled by St. Jude Medical Due to Due to a data migration from on-premises server...

Date: November 6, 2024
Company: St. Jude Medical
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical directly.

Affected Products

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.

Quantity: 25 systems

Why Was This Recalled?

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

Where Was This Sold?

This product was distributed to 13 states: CA, CT, GA, IL, MI, MN, NJ, NY, NC, OR, PA, TX, WA

Affected (13 states)Not affected

About St. Jude Medical

St. Jude Medical has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report