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U.S. Department of Health and Human Services

Class 2 Device Recall CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

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 Class 2 Device Recall CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMsee related information
Date Initiated by FirmOctober 05, 2024
Date PostedJanuary 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0989-2025
Recall Event ID 95602
PMA NumberP100045 
Product Classification System, hemodynamic, implantable - Product Code MOM
ProductCARDIOMEMS 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
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
FEI Number 3004936110
Recalling Firm/
Manufacturer		 St. Jude Medical
387 Technology Cir Nw Ste 500
Atlanta GA 30313-2424
For Additional Information ContactMs. Shelley Lange
651-756-4091
Manufacturer 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Recall		As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 11/14-18/24, the firm sent an updated Notification informing customer that Abbott is recommending replacement of the affected Patient Electronics System (PES) that are resisting correction of their configuration file. On 12/13-16/2024, the firm sent an updated Notification for the Hospital Electronic Systems (HES) regarding inaccurate Pulmonary Artery (PA) reading. On October 15, 2024, Abbott initiated a database correction to return affected PES to their intended configuration files. After continued monitoring, Abbott has identified a subset of units that is resisting correction and is retaining their incorrect configuration file. To ensure impacted PES units return to transmission of accurate data, Abbott recommends that clinicians take the following actions: 1 Review the attached appendix which includes a complete listing of impacted patients PES systems. -Patients with a date listed have already successfully connected and resumed sending accurate data. This date corresponds to the return of accurate PA pressures being sent by the PES. From this date forward, the data may be used for patient management. -Patients without a date listed have not yet resumed sending accurate data. Please encourage patients to send daily data transmissions (PES readings) to ensure the correction can be initiated. 2 PA pressures taken between 9/30/2024 and the listed date on the attachment may still not be accurate even after the database correction and it is recommended not to use for patient management. For HES units, review the appendix to see patient sensors that have been impacted by the affected HES between September 30, 2024 and the HES correction date, and take action as recommended below: 1 If the HES was used to take a follow-up pressure reading it is recommended to ignore that reading for clinical decision making or patient management. 2 If the affected HES was used for implant or recalibration, please contact Abbott Rep or Remote Care Technical Support at 1-844
Quantity in Commerce431 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MOM
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