CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PE...
FDA Device Recall #Z-0989-2025 — Class II — October 5, 2024
Recall Summary
| Recall Number | Z-0989-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | St. Jude Medical |
| Location | Atlanta, GA |
| Product Type | Devices |
| 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As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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.
Lot / 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 from St. Jude Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1427-2025 | Class II | CardioMEMS Heart Failure (HF) System that consi... | Feb 3, 2025 |
| Z-0987-2025 | Class II | Merlin.net Patient Care Network (PCN) Heart Fai... | Nov 6, 2024 |
| Z-0988-2025 | Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Card... | Oct 5, 2024 |
| Z-2348-2024 | Class II | St. Jude Medical Agilis NxT Steerable Introduce... | Apr 30, 2024 |
| Z-0218-2024 | Class II | CardioMEMS Patient Electronic System (PES), Mod... | Oct 4, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.