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U.S. Department of Health and Human Services

Class 1 Device Recall Carotid WALLSTENT Monorail Endoprosthesis Closed Cell SelfExpanding Stent

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 Class 1 Device Recall Carotid WALLSTENT Monorail Endoprosthesis Closed Cell SelfExpanding Stentsee related information
Date Initiated by FirmJuly 07, 2025
Date PostedAugust 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2273-2025
Recall Event ID 97243
PMA NumberP050019 
Product Classification Stent, carotid - Product Code NIM
ProductCarotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;
Code Information 1. H7493915010240 UDI-DI 08714729781097 Batches 35277608 35315983 35315984 35315985 35380314 35452835 35452836 35514614 35551688 35551689 35664523 35664524 35750157 35750158 35750159 35750400 35879409 35879410 35921915 35922951 35926817 35926818 35942366 36056965 36058841 36058842 36058843 36096638 36121883 36138618 36138619 36138801 36138802 36138803 36159671 36195057 36195058 36195059 36195360 36205167 36209423 36214805 36214806 36256192 36322725 36348207 36348208 36348209 36498256 36588496 36607566 36711321; 2. H7493915010310 UDI-DI 08714729781110 Batches 35294379 35294540 35295922 35330503 35330504 35336132 35347263 35382292 35383351 35383352 35453002 35461487 35461488 35528579 35529200 35628964 35628965 35628966 35641995 35662047 35664484 35664485 35750401 35750402 35750403 35750404 35750405 35750406 35750407 35890012 35893584 35893585 35894358 35894359 35938922 35938923 35938924 35938925 35938926 36002641 36002642 36063291 36063292 36105446 36133161 36134808 36144148 36148535 36154091 36154092 36154093 36154094 36154095 36169871 36169872 36197809 36197810 36197811 36197812 36197813 36200118 36202762 36204350 36212466 36212467 36212468 36256193 36256194 36256195 36357711 36357712 36368143 36368144 36368145 36516036 36603362 36603363 36642784 36683543 36688775 36811476 36811477 36818953; 3. H749391506220 UDI-DI 08714729781158 Batches 35582211 35750408 35947814 35947815 35950476 36009906 36292862 36397124 36652844; 4. H749391508210 UDI-DI 08714729781172 Batches 35343574 35438658 35487375 35567637 35652700 35656388 35750409 35757024 35873346 35873347 35901381 35901382 35999854 35999855 35999856 36246587 36246588 36246589 36292863 36306518 36376412 36410418 36410419 36412851 36479267 36565560 36636529 36724350 36777341 5. H749391508290 UDI-DI 08714729781196 Batches 35339488 35375416 35375417 35462381 35529285 35529286 35617101 35617102 35618276 35662042 35662043 35749222 35750156 35750410 35750411 35750412 35750413 35771618 35944023 35944024 35946987 35946988 35950477 35950478 35950479 35951080 35951081 35951082 35951083 35961400 35978120 36320917 36320918 36320919 36321560 36322143 36458848 36458849 36458850 36458851 36458852 36465397 36465398 36465399 36505552 36505553 36607622 36683540 36792075; 6. H965SCH647010 UDI-DI 08714729263869 Batches 35347272 35347273 35347274 35432322 35432323 35432324 35432325 35435587 35496538 35496539 35510448 35510449 35549114 35558691 35558692 35623470 35623471 35623472 35641992 35757022 35891995 35891996 35903878 35903879 35904080 35904081 35911104 35911106 35926007 35926017 35990353 35990354 36009907 36012786 36012787 36012788 36012789 36222681 36222683 36241106 36241107 36241108 36292865 36292866 36292867 36292868 36292869 36292870 36297506 36297507 36348203 36348204 36357034 36357035 36357037 36402896 36402897 36469383 36469384 36469385 36493671 36515107 36609942 36609943 36609944 36717345 36722322 36769772 36769773 36787067; 7. H965SCH647070 UDI-DI 08714729263876 Batches 35240183 35240184 35240185 35241830 35241831 35242395 35244198 35302653 35302654 35345323 35345324 35345325 35353957 35353958 35353959 35355526 35355527 35355528 35355529 35355530 35355531 35355532 35355533 35355534 35355535 35388600 35388601 35388602 35388603 35388604 35388605 35390839 35432326 35435588 35435589 35435590 35435591 35435592 35435593 35435594 35435595 35435596 35435597 35435598 35435599 35435640 35435641 35435642 35438652 35438653 35438654 35438659 35448174 35448175 35448261 35448262 35448263 35448264 35487376 35487377 35489534 35489535 35489536 35494158 35494159 35495360 35495361 35495362 35495363 35497060 35497061 35497062 35507545 35507546 35514618 35548744 35549113 35553916 35553917 35553918 35553919 35556850 35556851 35558690 35565001 35565003 35567636 35567638 35574827 35580272 35580273 35580274 35580275 35580276 35582209 35582210 35584963 35588884 35588885 35588886 35610418 35610419 35618278 35618279 35620887 35620888 35622207 35643329 35646460 35646461 35646462 35646465 35646466 35646467 35646469 35646470 35646471 35646472 35646473 35652701 35652702 35652703 35656390 35771619 35771720 35771721 35771722 35771723 35771724 35774933 35774935 35912369 35912370 35912371 35912372 35913736 35934661 35934662 35934663 35934664 35936385 35936386 35936388 35937854 35937855 35937961 35937962 35938832 35938833 35944025 35944026 35944027 35944028 35946402 35946403 35952677 35952678 35952679 35952740 35960613 35960614 35960615 35960616 35960617 35960618 35960619 35970056 35970057 35970482 35970483 35972008 35972009 35972010 35972011 35974039 35974900 35974902 35974903 35978121 35978122 35979584 35979585 35985615 35985616 35988023 35989721 35999859 35999920 35999976 35999977 36058848 36058849 36058850 36058851 36058852 36058853 36058854 36066439 36066960 36067793 36067794 36067795 36067796 36067797 36067798 36067799 36068080 36072053 36072054 36091095 36091096 36091097 36093208 36093209 36093740 36093741 36094572 36094573 36099091 36099092 36099093 36103432 36103433 36230819 36231140 36233435 36233436 36233437 36233438 36241642 36241643 36241660 36241661 36243288 36243289 36243290 36246584 36246585 36246586 36246590 36246591 36246592 36246593 36246594 36247809 36247810 36247811 36247812 36251034 36251035 36251036 36251037 36251038 36261365 36261704 36266101 36266102 36266103 36266104 36278239 36278520 36278521 36278522 36278523 36278524 36278525 36281013 36281014 36281015 36281016 36281017 36281018 36281019 36281520 36281521 36281522 36285859 36286700 36286701 36286702 36286703 36286704 36286705 36286706 36286707 36286708 36287360 36287361 36292139 36292861 36297762 36301606 36301607 36301608 36301609 36301610 36301611 36301612 36301613 36301614 36301615 36306516 36306517 36352994 36352996 36352997 36352999 36353020 36353022 36353023 36353025 36353026 36353028 36357708 36357709 36357710 36362685 36362686 36362687 36362688 36362689 36362690 36362691 36362692 36362693 36362694 36368150 36368151 36368152 36368153 36368154 36372913 36372914 36372915 36372916 36372917 36372918 36372919 36373140 36373141 36373142 36376410 36376411 36402898 36402899 36403020 36408269 36408270 36408271 36408272 36408273 36408274 36408275 36408276 36408277 36408278 36408279 36410417 36412854 36423241 36423242 36469386 36469387 36469388 36469389 36475479 36475580 36475581 36479261 36479262 36479263 36479264 36479265 36479266 36479268 36480347 36501126 36515108 36523367 36525434 36525435 36525437 36525438 36565561 36609945 36609946 36609947 36609948 36609950 36609951 36609952 36616128 36616129 36616130 36616131 36616132 36645415 36645416 36668237 36668238 36668239 36668460 36668461 36668462 36669215 36672359 36688777 36712752 36717346 36717347 36717348 36719378 36721745 36721746 36722177 36722179 36722320 36724346 36724347 36724348 36724349 36728508 36728509 36729021 36729022 36729023 36732219 36732360 36732361 36732362 36732974 36732976 36732977 36743995 36743996 36743997 36773856 36773857 36773858 36782024 36784204; 8. H965SCH647080 UDI-DI 08714729263883 Batches 35243220 35244199 35244520 35244521 35247274 35247275 35247276 35247277 35247278 35247279 35247540 35247541 35248292 35248293 35248294 35252806 35252808 35252809 35302655 35302656 35302657 35302658 35304581 35305305 35305306 35307512 35307513 35307514 35339484 35339485 35339486 35339487 35357498 35357499 35357740 35361258 35361259 35361460 35361461 35361462 35361463 35362807 35362808 35365037 35365038 35365039 35365800 35365801 35365802 35365803 35365804 35365805 35367555 35370836 35370837 35370838 35370839 35371180 35371181 35371182 35371183 35375418 35375419 35388606 35388607 35388608 35388609 35388610 35388611 35391026 35391027 35391028 35391029 35391030 35393507 35393508 35393509 35393510 35393511 35393512 35394158 35394159 35395620 35395621 35395622 35395623 35395624 35395625 35395626 35395627 35397442 35397443 35397444 35397445 35402251 35402254 35402257 35402280 35402283 35402284 35406000 35406001 35448176 35448177 35450110 35450111 35450112 35450113 35456213 35456215 35456216 35456217 35457525 35457526 35458769 35461739 35461741 35461742 35462380 35462382 35462383 35465421 35465422 35465423 35465424 35468042 35468043 35468044 35468045 35468046 35468047 35468048 35468049 35468050 35468051 35471389 35471390 35471391 35471392 35471393 35476347 35476348 35514612 35518815 35519420 35520154 35520155 35520156 35522424 35522425 35522699 35522780 35522781 35522782 35522977 35522978 35522979 35523220 35523221 35523222 35525808 35525809 35525810 35525811 35526986 35526987 35526988 35528577 35528578 35529284 35529287 35529629 35529630 35529631 35529632 35531670 35531671 35531672 35541480 35541481 35541482 35541483 35542643 35562259 35562520 35565634 35565635 35565636 35585834 35585835 35585836 35585838 35589525 35589526 35590013 35590014 35611923 35611924 35612128 35612129 35612130 35612131 35612132 35612143 35612144 35613461 35613462 35613463 35613464 35613465 35616796 35616797 35616798 35616799 35617100 35618178 35618179 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36416042 36416043 36416044 36416334 36416335 36416336 36416337 36416338 36416339 36416420 36422413 36422414 36422598 36422599 36423963 36423964 36423965 36423995 36423996 36447747 36447748 36447749 36448144 36448145 36448156 36448157 36449975 36449976 36449977 36453798 36455025 36455026 36458843 36458844 36458845 36458846 36458847 36480348 36480349 36480350 36480351 36485714 36485715 36485716 36485717 36485718 36485719 36485800 36485801 36485802 36485803 36485851 36485852 36491169 36491170 36491171 36491172 36491173 36491174 36493672 36493673 36493674 36493675 36493676 36493677 36498253 36498254 36498255 36501125 36508768 36508771 36508772 36508773 36508774 36525439 36529070 36529071 36529072 36529073 36529074 36529075 36529076 36529077 36529078 36529079 36535347 36535348 36535349 36535352 36535353 36535354 36535355 36539304 36539306 36545277 36545278 36545279 36545760 36545761 36548829 36548830 36552374 36553653 36553654 36553655 36554562 36554563 36554564 36554565 36554566 36555138 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36748008 36749662 36749663 36761491 36761492 36765445 36765446 36767807 36784206 36785292 36785384 36785385 36787969 36787970 36787971 36788799 36792076 36792077 36793502 36793503 36793678 36793679 36795349 36795350 36795351 36799042 36799043 36801653 36803154 36803155 36817363 36818518 36818519; 9. H965SCH647090 UDI-DI 08714729263890 Batches 35284214 35284216 35284217 35296025 35296026 35296027 35307517 35309535 35309536 35313433 35313434 35313435 35343571 35376080 35376081 35376082 35376083 35395628 35395629 35395630 35406003 35452838 35471394 35471395 35471396 35471397 35471398 35476350 35476351 35476352 35476819 35476960 35514613 35541484 35541485 35541486 35541487 35542644 35542645 35542646 35542647 35588888 35588889 35588890 35594003 35600380 35600381 35600716 35600717 35600718 35663304 35663305 35663307 35663958 35663959 35664480 35664482 35667604 35749225 35749227 35749228 35778247 35778248 35778249 35778250 35893582 35893583 35928594 35928595 35950473 35950474 35950475 35964009 35964010 35972012 35980330 35980331 36007692 36007693 36007694 36007695 36007696 36018041 36018042 36033496 36033497 36033498 36033499 36033880 36043497 36043498 36043499 36043780 36055146 36055147 36055785 36056677 36078428 36097193 36116118 36116119 36116120 36220947 36322723 36322724 36328322 36328323 36328324 36341859 36342380 36342381 36342382 36342383 36342384 36342385 36342386 36342387 36342388 36347198 36347199 36347220 36347221 36347222 36347223 36347224 36347225 36347226 36357714 36357715 36378272 36378273 36465500 36465501 36469380 36469381 36469382 36475477 36475478 36508775 36508776 36513257 36513258 36513259 36513760 36518682 36518683 36553656 36553657 36553658 36553659 36554560 36563910 36582970 36582971 36582972 36582973 36582974 36595826 36595828 36635529 36635530 36635531 36646050 36646051 36679165 36688435 36712758 36717344 36795885 36817573; 10. H965SCH647120 UDI-DI 08714729263906 Batches 35258269 35258270 35258273 35258274 35260228 35260229 35265522 35265523 35266396 35266397 35266398 35266399 35267871 35267872 35272291 35272292 35273687 35273688 35273689 35274001 35274002 35274003 35274004 35276183 35276184 35276185 35276186 35276187 35277609 35278162 35278163 35278164 35278165 35278167 35281328 35281329 35289305 35306610 35306611 35306612 35310693 35310694 35310695 35310696 35315986 35315987 35315988 35320538 35320539 35324563 35324564 35324565 35324566 35324567 35324568 35324569 35376084 35376085 35376087 35380104 35380105 35380315 35380316 35381858 35381859 35381980 35381981 35381982 35381983 35381984 35395631 35395632 35395633 35406004 35406005 35406007 35406008 35406009 35406010 35409844 35409845 35409847 35409848 35409849 35409851 35409852 35409853 35416153 35416154 35452819 35453000 35461486 35480117 35480118 35480946 35480947 35480948 35480949 35484493 35484494 35487378 35487379 35501516 35501517 35514615 35514616 35514617 35515702 35517161 35519704 35545687 35545688 35545689 35545690 35545691 35546819 35547736 35547737 35551690 35551691 35551692 35565638 35565640 35565641 35565642 35565643 35569825 35569826 35569827 35594002 35626901 35665247 35667601 35667602 35671453 35671454 35671455 35671456 35671457 35673280 35890013 35890014 35895660 35895661 35901388 35901389 35921353 35921354 35921355 35921356 35942368 35998696 35998697 35998698 36001798 36001799 36002640 36009902 36009903 36009904 36009905 36012794 36043495 36043496 36056678 36056679 36056960 36056961 36056964 36058844 36058845 36058846 36058847 36063287 36063288 36063290 36068087 36068088 36068089 36068090 36095403 36095404 36095405 36095406 36096639 36101301 36101302 36101699 36102320 36102321 36102324 36102325 36103434 36103435 36103436 36105447 36105448 36111547 36111548 36111549 36111551 36111552 36112953 36112954 36112955 36112956 36112957 36121884 36138616 36138617 36138800 36138804 36138805 36159666 36159667 36159668 36159669 36159670 36159672 36159673 36164841 36164842 36164843 36169145 36169146 36169147 36169148 36169867 36169868 36169869 36173875 36173876 36179702 36179703 36180136 36193169 36193170 36193171 36193172 36193173 36195518 36195519 36195580 36195581 36195582 36205168 36205169 36208940 36208941 36209024 36209025 36209424 36224696 36224697 36234046 36234047 36234048 36498257 36498258 36498259 36501127 36586444 36586445 36586446 36586447 36588495 36588497 36591213 36591214 36593068 36593069 36607567 36640275 36640276 36640277 36679166 36683542 36688773 36688774 36698998 36698999 36711322 36711323 36787078 36789908 36789909 36796820 36800990 36803152 36834285; 11. 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H965SCH647140 UDI-DI 08714729263920 Batches 35272289 35272290 35278747 35278748 35293817 35293818 35293819 35309703 35309704 35309705 35309706 35320537 35329976 35329978 35329979 35341681 35341682 35344559 35345321 35345329 35347267 35347268 35347269 35383621 35386679 35386780 35386781 35388276 35388277 35428800 35428801 35428802 35428803 35484499 35489527 35489530 35489533 35496534 35496535 35496536 35525178 35530635 35560220 35560221 35560222 35566231 35625591 35625592 35641157 35641460 35677035 35677036 35677037 35677038 35682786 35682787 35682788 35682789 35682790 35682791 35778251 35778252 35987778 35987779 36066437 36066438 36072052 36072851 36072852 36072854 36105453 36115283 36115284 36124482 36132938 36132939 36133160 36134809 36154986 36159663 36164696 36164697 36164698 36164699 36179704 36179705 36179706 36195056 36202763 36205164 36213495 36213496 36213572 36213573 36213574 36213575 36498341 36501128 36501129 36606591 36652845 36652846 36773180 36773181 36773182 36775992 36775994 36818514 36818515; 13. M001719000 UDI-DI 08714729781165 Batches 35438655 35438656 35438657 35641993 35641994 36053998 36053999 36223361 36223362 36348206 36523368 36616127 36777256 14. M001719010 UDI-DI 08714729781189 Batches 35252807 35307515 35307516 35355536 35450114 35450115 35504179 35504200 35504201 35571041 35583635 35583636 35583637 36223363 36223364 36224129 36224132 36224133 36230818 36297515 36297516 36297518 36297761 36368141 36368142 36412855 36475475 36539307 36616133 36616134 36739202 15. M001719020 UDI-DI 08714729781202 Batches 35252812 35343568 35343569 35343570 35343572 35355537 35379661 35406002 35476349 35480115 35480116 35542648 35560230 35560231 35629995 35629996 35629997 35636546 35636547 35662002 35662003 35961401 35961402 35961403 35961404 35961405 35970484 35972013 35977619 36006440 36007615 36007616 36007618 36271662 36271663 36271664 36271665 36271666 36275712 36275713 36275714 36275715 36275716 36299150 36299151 36299152 36299153 36299154 36306787 36306788 36397121 36397122 36453791 36453792 36453793 36453795 36475476 36552375 36552376 36565457 36617888 36630791 36633072 36635526 36767805 36767806; 16. M001719030 UDI-DI 08714729781226 Batches 35343573 35347264 35379662 35476961 35476962 35545686 35550309 35550605 35589532 35664483 35749224 35980332 35980333 35997086 36018043 36078429 36087098 36087099 36087540 36096632 36096633 36347227 36397123 36416430 36416431 36563911 36565458 36565459 36635532 36635533; 17. M001719040 UDI-DI 08714729781103 Batches 35281323 35281324 35281325 35324570 35324571 35416155 35484495 35547738 35623469 36113886 36113887 36115281 36115282 36124259 36124480 36124481 36169150 36209425 36498340 36711739 36712757 36713869; 18. M001719050 UDI-DI 08714729781127 Batches 35293814 35295923 35347265 35347266 35388278 35485560 35553939 35641991 35682792 35939213 35939214 35939215 35939216 36065524 36065525 36065526 36148529 36148532 36508770 36606592 36771557 36817706; 19. M001719060 UDI-DI 08714729781141 Batches 35310697 35315981 35315982 35347270 35388279 35496537 35566234 35682793 35978123 36043781 36105452 36159664 36159665 36164840 36498342
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactClara Johnson
763-494-1700
Manufacturer Reason
for Recall		Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
FDA Determined
Cause 2		Process change control
ActionOn July 7, 2025, the firm sent "Urgent Medical Device Removal" customer notifications to all affected accounts either via FedEx Overnight Delivery or in person delivery by sales representatives. The letter provided customers with information about identifying the product and instructions for product segregation and return. 1. Further distribution or use of any remaining devices (Attachment 1) affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form via email: BSCFieldActionCenter@bsci.com or fax: BSC Field Action Center 1-763-415-7708. 5. Return affected devices to Boston Scientific. If you have any questions, call the Quality Systems Manager II at 763-494-1700.
Quantity in Commerce26,570 (1,333 US; 25,174 OUS)
DistributionDomestic US Nationwide distribution including Puerto Rico. International distribution worldwide.
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 = NIM
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