🔍 RecallPedia

CARDIOMEMS 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

Class I - Dangerous
🏥 Medical Devices Recalled: October 5, 2024 St. Jude Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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 P210600328 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P240300379 518872569 CM1100 P190214238 520502048 CM1100 P190600463 523073526 CM1100 P210500194 523413813 CM1100 P230100030 525600276 CM1100 P230100618 528575541 CM1100 P231100039 529075954 CM1100 P220601113 531902971 CM1100 P220100442 533161279 CM1100 P210200287 537268872 CM1100 P210100241 541387478 CM1100 P201200110 542890504 CM1100 P230600172 544878077 CM1100 P240500279 548079920 CM1100 P180912565 548337351 CM1100 P220400170 554641290 CM1100 P230200905 559011242 CM1100 P220100084 563392091 CM1100 P200100185 563393867 CM1100 P240400032 565899812 CM1100 P240300749 566845483 CM1100 P220800221 567619564 CM1100 P180912421 570331462 CM1100 P240400315 574608816 CM1100 P171006324 575367487 CM1100 P190500320 575751227 CM1100 P190500218 576525729 CM1100 P190400314 576755615 CM1100 P171006229 579037078 CM1100 P240300013 579917048 CM1100 P191100200 581159357 CM1100 P240400434 584384242 CM1100 P200800193 585309040 CM1100 P240100144 585385362 CM1100 P240100500 585776347 CM1100 P210500150 587345547 CM1100 P181113137 588282160 CM1100 P210300707 591516646 CM1100 P220100583 591582986 CM1100 P180409773 592241806 CM1100 P220601266 592748172 CM1100 P220800352 593964315 CM1100 P231000284 595785213 CM1100 P190113867 598081636 CM1100 P230800062 598880136 CM1100 P230300544 599754991 CM1100 P240200125 604960369 CM1100 P200100389 605049881 CM1100 P210100550 607262144 CM1100 P200500212 608065025 CM1100 P240300612 608360426 CM1100 P170604566 609922372 CM1100 P240800612 611670993 CM1100 P230500624 612076232 CM1100 P200100440 614992014 CM1100 P240600470 616754834 CM1100 P221100149 617507090 CM1100 P240300691 619439599 CM1100 P240100460 621482165 CM1100 P240200003 622754570 CM1100 P221100870 624194502 CM1100 P240100148 624680724 CM1100 P220800734 625199443 CM1100 P191000264 628310179 CM1100 P190900429 629565268 CM1100 P230700303 631102530 CM1100 P230500407 631744810 CM1100 P191000173 632858882 CM1100 P230300575 635604564 CM1100 P230100090 635758147 CM1100 P190500437 636872905 CM1100 P170202924 639572148 CM1100 P230600726 642304745 CM1100 P230900155 645873274 CM1100 P221000242 648482446 CM1100 P201200026 651159881 CM1100 P200600159 655100725 CM1100 P200500359 655194108 CM1100 P221100810 655610533 CM1100 P211000805 658356548 CM1100 P230200048 661284158 CM1100 P210800277 662122597 CM1100 P230300434 664211844 CM1100 P230500364 664481181 CM1100 P240100563 665295333 CM1100 P170403567 665876389 CM1100 P240400554 665951562 CM1100 P181012699 666566716 CM1100 P210201742 667673305 CM1100 P211000032 670348416 CM1100 P230300121 671566222 CM1100 P200100645 671689248 CM1100 P220700363 673361846 CM1100 P230200471 674022702 CM1100 P231000282 674381496 CM1100 P240400424 675903546 CM1100 P230300345 677916777 CM1100 P220700442 678702556 CM1100 P171006174 680165248 CM1100 P240600437 681661054 CM1100 P240200022 683291496 CM1100 P230800016 684586274 CM1100 P240300405 685343600 CM1100 P230800158 686032103 CM1100 P230600743 686933599 CM1100 P220600726 689708394 CM1100 P180711232 694165630 CM1100 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CM1100 P240400458 931322200 CM1100 P220400922 936060623 CM1100 P240200096 938609021 CM1100 P230700237 939617007 CM1100 P170504272 940480338 CM1100 P240300433 940521495 CM1100 P170303264 940932684 CM1100 P170202310 941742918 CM1100 P211000087 942358482 CM1100 P190700244 943421438 CM1100 P230800828 946803467 CM1100 P221100125 948067095 CM1100 P220300245 949476246 CM1100 P230400673 950677823 CM1100 P240300790 950772632 CM1100 P230200723 953281755 CM1100 P240200067 953715968 CM1100 P210500191 955545645 CM1100 P220400831 962725750 CM1100 P221000207 962980850 CM1100 P240300476 965949571 CM1100 P230500704 971509831 CM1100 P230400215 974042541 CM1100 P230700057 976587576 CM1100 P170805497 977722453 CM1100 P220200203 978030971 CM1100 P230800110 978664092 CM1100 P211200166 978757540 CM1100 P190700603 979688181 CM1100 P190214450 979999620 CM1100 P221100659 980222624 CM1100 P230800136 981499353 CM1100 P220900133 981833593 CM1100 P180208707 986810596 CM1100 P191000301 988054110 CM1100 P240400522 988866935 CM1100 P210700912 992239657 CM1100 P230200873 995330511 CM1100 P230800017
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
St. Jude Medical
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

CARDIOMEMS 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

Product Codes/Lot Numbers:

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 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CM1100 P210700912 992239657 CM1100 P230200873 995330511 CM1100 P230800017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0988-2025

Related Recalls

CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

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Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

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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

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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.

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