Recall archive / FDA device enforcement

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.n... — FDA record Z-0988-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Classification: Class II
Recalling firm: St. Jude Medical
Quantity: 605 units
Agency-reported status: Ongoing
Source record identifier: Z-0988-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 089528947 CM1100 P231100056 091435883 CM1100 P230600230 091846907 CM1100 P190400092 092964808 CM1100 P220601351 093046498 CM1100 P180208408 096655907 CM1100 P200500395 097782585 CM1100 P220800056 097973184 CM1100 P210400470 097985105 CM1100 P220200308 098510456 CM1100 P180912257 098553217 CM1100 P230700024 098717770 CM1100 P180812191 103524443 CM1100 P190600308 105005185 CM1100 P240400232 106316250 CM1100 P240100164 110571163 CM1100 P231100263 110786878 CM1100 P200200279 111636379 CM1100 P191200030 112437421 CM1100 P190214131 112450366 CM1100 P220100031 114078702 CM1100 P220400840 114746951 CM1100 P220400246 115415655 CM1100 P200600103 117402925 CM1100 P200200448 121663629 CM1100 P240400540 123570731 CM1100 P240300559 124446626 CM1100 P220600722 125968610 CM1100 P220300255 129028643 CM1100 P240500155 129187100 CM1100 P240100092 130416936 CM1100 P220300540 130561434 CM1100 P220500091 131755126 CM1100 P240600068 134652791 CM1100 P211200310 135234896 CM1100 P180811660 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CM1100 P220601079 261777874 CM1100 P190800428 262395304 CM1100 P240300371 262778772 CM1100 P220200261 263605636 CM1100 P210900193 266524180 CM1100 P210500010 268267234 CM1100 P230200053 268484839 CM1100 P200600222 270074206 CM1100 P171106968 274979970 CM1100 P221100675 275289833 CM1100 P200100099 277187068 CM1100 P210600057 277220257 CM1100 P220200431 279610018 CM1100 P221100001 280474222 CM1100 P180812087 283021137 CM1100 P221100156 283696672 CM1100 P200500400 284467206 CM1100 P240100344 284692092 CM1100 P210700044 292458718 CM1100 P220700181 294186242 CM1100 P180710945 296152457 CM1100 P180912276 298042227 CM1100 P200500172 298070806 CM1100 P220800495 300912730 CM1100 P231000261 305500472 CM1100 P220500805 305819500 CM1100 P240200437 306426487 CM1100 P230800796 306758319 CM1100 P210700851 307202176 CM1100 P220300431 307880484 CM1100 P210600155 309781797 CM1100 P211200233 310695366 CM1100 P211000748 311217103 CM1100 P220601485 311631733 CM1100 P191000242 311934103 CM1100 P240300491 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CM1100 P210400103 449437243 CM1100 P230800031 451748636 CM1100 P240300335 453264376 CM1100 P210201464 458406519 CM1100 P240300775 461591992 CM1100 P230900435 462620105 CM1100 P180308803 464625540 CM1100 P230200657 467654000 CM1100 P230100489 470268780 CM1100 P240200471 478579014 CM1100 P230300065 479067118 CM1100 P220100317 480351741 CM1100 P240300777 482431962 CM1100 P190400060 482786886 CM1100 P191000323 483625521 CM1100 P210400623 485241988 CM1100 P220800322 486068760 CM1100 P211000369 489189498 CM1100 P220500635 489545228 CM1100 P200300547 490915188 CM1100 P161101333 491185856 CM1100 P191000488 492192455 CM1100 P180308850 494410608 CM1100 P230300210 497905380 CM1100 P171006384 500487129 CM1100 P210700039 501371454 CM1100 P171207485 502428865 CM1100 P240100213 502652464 CM1100 P240300751 503103988 CM1100 P240100035 505457945 CM1100 P220400441 505812966 CM1100 P220400326 508809456 CM1100 P240200163 514258540 CM1100 P221100638 514742907 CM1100 P191100429 515592285 CM1100 P190400108 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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 P240300107 698752292...

Label field

Details supplied by the agency

Lot, code or applicability

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 089528947 CM1100 P231100056 091435883 CM1100 P230600230 091846907 CM1100 P190400092 092964808 CM1100 P220601351 093046498 CM1100 P180208408 096655907 CM1100 P200500395 097782585 CM1100 P220800056 097973184 CM1100 P210400470 097985105 CM1100 P220200308 098510456 CM1100 P180912257 098553217 CM1100 P230700024 098717770 CM1100 P180812191 103524443 CM1100 P190600308 105005185 CM1100 P240400232 106316250 CM1100 P240100164 110571163 CM1100 P231100263 110786878 CM1100 P200200279 111636379 CM1100 P191200030 112437421 CM1100 P190214131 112450366 CM1100 P220100031 114078702 CM1100 P220400840 114746951 CM1100 P220400246 115415655 CM1100 P200600103 117402925 CM1100 P200200448 121663629 CM1100 P240400540 123570731 CM1100 P240300559 124446626 CM1100 P220600722 125968610 CM1100 P220300255 129028643 CM1100 P240500155 129187100 CM1100 P240100092 130416936 CM1100 P220300540 130561434 CM1100 P220500091 131755126 CM1100 P240600068 134652791 CM1100 P211200310 135234896 CM1100 P180811660 135686780 CM1100 P220400411 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P240400516 208772129 CM1100 P190214217 212681613 CM1100 P220600229 213719610 CM1100 P230700075 214403909 CM1100 P200200410 219149465 CM1100 P220200020 220570311 CM1100 P230600741 220801765 CM1100 P240300196 221186828 CM1100 P211000415 222745481 CM1100 P180309231 223692831 CM1100 P180409883 225728211 CM1100 P181012711 227541125 CM1100 P180610591 228372231 CM1100 P161000975 230252645 CM1100 P240100056 230334013 CM1100 P210400078 232604975 CM1100 P230600189 233939131 CM1100 P220600855 236466009 CM1100 P200600101 236768586 CM1100 P171006650 237203971 CM1100 P230800716 237263793 CM1100 P240400420 237987359 CM1100 P240900138 244016986 CM1100 P220500693 245197025 CM1100 P180711129 246163364 CM1100 P220500054 246340731 CM1100 P210700889 252307665 CM1100 P190113705 252386115 CM1100 P240500320 253106405 CM1100 P230200684 253613996 CM1100 P231000068 253830137 CM1100 P231000140 254778707 CM1100 P240200507 255438160 CM1100 P240100203 256944752 CM1100 P191000257 258523372 CM1100 P220601079 261777874 CM1100 P190800428 262395304 CM1100 P240300371 262778772 CM1100 P220200261 263605636 CM1100 P210900193 266524180 CM1100 P210500010 268267234 CM1100 P230200053 268484839 CM1100 P200600222 270074206 CM1100 P171106968 274979970 CM1100 P221100675 275289833 CM1100 P200100099 277187068 CM1100 P210600057 277220257 CM1100 P220200431 279610018 CM1100 P221100001 280474222 CM1100 P180812087 283021137 CM1100 P221100156 283696672 CM1100 P200500400 284467206 CM1100 P240100344 284692092 CM1100 P210700044 292458718 CM1100 P220700181 294186242 CM1100 P180710945 296152457 CM1100 P180912276 298042227 CM1100 P200500172 298070806 CM1100 P220800495 300912730 CM1100 P231000261 305500472 CM1100 P220500805 305819500 CM1100 P240200437 306426487 CM1100 P230800796 306758319 CM1100 P210700851 307202176 CM1100 P220300431 307880484 CM1100 P210600155 309781797 CM1100 P211200233 310695366 CM1100 P211000748 311217103 CM1100 P220601485 311631733 CM1100 P191000242 311934103 CM1100 P240300491 319975595 CM1100 P230500579 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P230400497 395640220 CM1100 P180510254 401490206 CM1100 P230900171 402109201 CM1100 P190214182 402255517 CM1100 P170604828 402628804 CM1100 P200100587 403698244 CM1100 P201000162 404279978 CM1100 P230500069 406139915 CM1100 P240500400 406381392 CM1100 P180208619 408445914 CM1100 P170303208 408786705 CM1100 P220400372 409199106 CM1100 P240600394 411912546 CM1100 P210600320 413136805 CM1100 P220600868 413733015 CM1100 P221100197 414185025 CM1100 P240300040 416763076 CM1100 P240500097 419042015 CM1100 P230500146 423411206 CM1100 P240300333 426439923 CM1100 P230300045 426469698 CM1100 P181213482 426530952 CM1100 P240300417 427359195 CM1100 P161001007 428398739 CM1100 P211001056 429436892 CM1100 P230500337 431784867 CM1100 P240200236 432437499 CM1100 P220200276 435690169 CM1100 P190500328 436517833 CM1100 P190800471 437546872 CM1100 P231000304 439719758 CM1100 P171006206 441354826 CM1100 P240500341 442096970 CM1100 P190600120 444494447 CM1100 P230200181 447222555 CM1100 P210400103 449437243 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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 P240300107 698752292...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 29, 2025
Recall initiation date: Oct 5, 2024
Center classification date: Jan 17, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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