FDA Medical devices recall ·
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model… recall
- Recall number
- Z-0987-2025
- Date
- (initiated November 6, 2024)
- Company / brand
- St. Jude Medical
387 Technology Cir Nw Ste 500, Atlanta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 25 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A
States: California Connecticut Georgia Illinois Michigan Minnesota North Carolina New Jersey New York Oregon Pennsylvania Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0987-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.