CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.n
Summary
The FDA issued a Class II for CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Elect by St. Jude Medical. Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect.
Details
Source
Device Recall
External ID
Z-0989-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 431 units
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As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-05
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
St. Jude Medical has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical have FDA actions?
St. Jude Medical has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0989-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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