CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report

Merlin.net Patient Care Network recalled by St. Jude Medical

St. Jude Medical is recalling Merlin.net Patient Care Network (PCN) Heart Failure Web Application (, distributed in 13 states. The recall was initiated on 6 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMerlin.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

Quantity recalled25 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0987-2025
FDA event ID: 95706
Recalling firm: St. Jude Medical, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Nov 2024
FDA classified: 17 Jan 2025
Reported: 29 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

6 Nov 2024	Recall initiated by company
17 Jan 2025	Classified by FDA	+72 days
29 Jan 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

California Connecticut Georgia Illinois Michigan Minnesota North Carolina New Jersey New York Oregon Pennsylvania Texas Washington

Questions about this recall

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from St. Jude Medical

All 47

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN
15 Mar 2023Device	CLASS II	CardioMEMS HF System Patient Electronics System (PES) recalled	St. Jude Medical	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide