Home / Recalls / St. Jude Medical / Z-0989-2025

Z-0989-2025 Class II Ongoing

Recalled by St. Jude Medical — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
January 29, 2025
Initiation Date
October 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
431 units

Product Description

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

Reason for Recall

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada.

Code Information

MN6000 (Which interfaces with CM3000 for HES) UDI-DI Code: 05414734510035 HES Serial Number/Clinic Merlin ID: M140400470 50011924 M140901162 50012084 M150102238 50013199 M150302655 50011863 M150905419 100351 M161107929 50012353 M161207976 50012166 M170108094 50011331 M170208159 50012146 M170208161 100268 M170408244 50015053 M170508275 50000752 M171108426 50051809 M171108437 50011840 M171108442 50011887 M180208509 50011887 M180308526 100710 M180608651 50011332 M180608652 50025010 M180608653 50015252 M180608669 50015252 M180608712 50060412 M180608727 50017544 M181008882 50038595 M190208990 50040301 M190208994 50040237 M190300010 50011866 M190400008 500150 M190700005 100605 M200400018 100359 M200600002 100351 M200600007 100080 M200800004 50050337 M200900014 50016848 M201100007 50050201 M210100003 9008126 M210300009 50014260 M210300011 50054572 M210300022 50013502 M210300023 50011879 M210900025 12000635 M211000003 50017405 M220600048 50025317

Other recalls by St. Jude Medical

  • Z-1427-2025 Class II — CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital Syst (February 3, 2025)
  • Z-0987-2025 Class II — Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN600 (November 6, 2024)
  • Z-0988-2025 Class II — CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electr (October 5, 2024)
  • Z-2348-2024 Class II — St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 (April 30, 2024)
  • Z-0218-2024 Class II — CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for w (October 4, 2023)
  • Z-1218-2023 Class II — CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The (February 7, 2023)
  • Z-1219-2023 Class II — CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The (February 7, 2023)
  • Z-1223-2023 Class II — CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The Car (February 7, 2023)
  • Z-1221-2023 Class II — CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The (February 7, 2023)
  • Z-1224-2023 Class II — CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The Car (February 7, 2023)