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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-0988-2025
Recall Event ID 95602
PMA NumberP100045 
Product Classification System, hemodynamic, implantable - Product Code MOM
ProductCARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 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 CM1100 for PES) UDI-DI Code: 05414734510035 Merlin ID / PES Serial Number: 027556711 CM1100 P180912371 444058655 CM1100 P240100658 494955560 CM1100 P230300384 497887091 CM1100 P180208671 513914390 CM1100 P230800825 742148364 CM1100 P220800695 751954397 CM1100 P211200289 000697912 CM1100 P181013064 001545862 CM1100 P220400808,P220100189 003473584 CM1100 P211100353 005842000 CM1100 P230100314 006333918 CM1100 P220600729 008418758 CM1100 P240300492 010473700 CM1100 P210700575 010485845 CM1100 P220100057 011307774 CM1100 P190800198 013397427 CM1100 P220500363 018103333 CM1100 P210201417 018852830 CM1100 P190900022 019716455 CM1100 P221100752 020956348 CM1100 P230500703 021148283 CM1100 P160900736 021410246 CM1100 P230800171 023874951 CM1100 P230400238 024386088 CM1100 P200100300 026473926 CM1100 P240500531 031880776 CM1100 P240300135 032455370 CM1100 P240300138 034701771 CM1100 P230300580 037825221 CM1100 P240100040 039458344 CM1100 P190700191 042069666 CM1100 P221200307 043804384 CM1100 P220401019 044375798 CM1100 P200100451 046139531 CM1100 P210400699 046659165 CM1100 P220700471 049107915 CM1100 P220600696 049584410 CM1100 P230800848 053752093 CM1100 P230900101 053919908 CM1100 P200600006 054799366 CM1100 P211100584 055804058 CM1100 P180912650 056345895 CM1100 P210200735 057332710 CM1100 P240100823 058913997 CM1100 P240100775 060968161 CM1100 P240200495 061420626 CM1100 P230500071 062897822 CM1100 P240300373 066957044 CM1100 P210700838 067353847 CM1100 P240300708 067723346 CM1100 P240400015 068715747 CM1100 P220600972 069131084 CM1100 P200100430 069742013 CM1100 P230900257 069865251 CM1100 P230100100 073642522 CM1100 P230300687 074384090 CM1100 P200300463 076330232 CM1100 P210600422 077130896 CM1100 P230700227 077880912 CM1100 P240100412 079272753 CM1100 P240300622 081971756 CM1100 P221100962 082613308 CM1100 P230100076 083258111 CM1100 P230200980 083964213 CM1100 P240600232 087932182 CM1100 P200300339 088913132 CM1100 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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 Commerce605 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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