Reported Aug 20, 2025 · Ongoing
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
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Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers
19 of 19 products
| # | Product as published |
|---|---|
| 1 | H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24 |
| 2 | H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31 |
| 3 | H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22 |
| 4 | H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21 |
| 5 | H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29 |
| 6 | H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22 |
| 7 | H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21 |
| 8 | H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29 |
| 9 | H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36 |
| 10 | H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24 |
| 11 | H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31 |
| 12 | H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37 |
| 13 | M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM |
| 14 | M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM |
| 15 | M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM |
| 16 | M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM |
| 17 | M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM |
| 18 | M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM |
| 19 | M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM |
- Lot codes and dates
- 1. H7493915010240 UDI-DI 08714729781097 Batches36711321; 2. H7493915010310 UDI-DI 08714729781110 Batches
352776083531598335315984353159853538031435452835354528363551461435551688355516893566452335664524357501573575015835750159357504003587940935879410359219153592295135926817359268183594236636056965360588413605884236058843360966383612188336138618361386193613880136138802361388033615967136195057361950583619505936195360362051673620942336214805362148063625619236322725363482073634820836348209364982563658849636607566
36818953; 3. H749391506220 UDI-DI 08714729781158 Batches82 of 82 codes
352943793529454035295922353305033533050435336132353472633538229235383351353833523545300235461487354614883552857935529200356289643562896535628966356419953566204735664484356644853575040135750402357504033575040435750405357504063575040735890012358935843589358535894358358943593593892235938923359389243593892535938926360026413600264236063291360632923610544636133161361348083614414836148535361540913615409236154093361540943615409536169871361698723619780936197810361978113619781236197813
36652844; 4. H749391508210 UDI-DI 08714729781172 Batches3558221135750408359478143594781535950476360099063629286236397124
5. H749391508290 UDI-DI 08714729781196 Batches3534357435438658354873753556763735652700356563883575040935757024358733463587334735901381359013823599985435999855359998563624658736246588362465893629286336306518363764123641041836410419364128513647926736565560366365293672435036777341
36792075; 6. H965SCH647010 UDI-DI 08714729263869 Batches353394883537541635375417354623813552928535529286356171013561710235618276356620423566204335749222357501563575041035750411357504123575041335771618359440233594402435946987359469883595047735950478359504793595108035951081359510823595108335961400359781203632091736320918363209193632156036322143364588483645884936458850364588513645885236465397364653983646539936505552365055533660762236683540
36787067; 7. H965SCH647070 UDI-DI 08714729263876 Batches69 of 69 codes
353472723534727335347274354323223543232335432324354323253543558735496538354965393551044835510449355491143555869135558692356234703562347135623472356419923575702235891995358919963590387835903879359040803590408135911104359111063592600735926017359903533599035436009907360127863601278736012788360127893622268136222683362411063624110736241108362928653629286636292867362928683629286936292870362975063629750736348203363482043635703436357035363570373640289636402897364693833646938436469385
36784204; 8. H965SCH647080 UDI-DI 08714729263883 Batches440 of 440 codes
352401833524018435240185352418303524183135242395352441983530265335302654353453233534532435345325353539573535395835353959353555263535552735355528353555293535553035355531353555323535553335355534353555353538860035388601353886023538860335388604353886053539083935432326354355883543558935435590354355913543559235435593354355943543559535435596354355973543559835435599354356403543564135435642354386523543865335438654354386593544817435448175354482613544826235448263354482643548737635487377
36818519; 9. H965SCH647090 UDI-DI 08714729263890 Batches804 of 804 codes
352432203524419935244520352445213524727435247275352472763524727735247278352472793524754035247541352482923524829335248294352528063525280835252809353026553530265635302657353026583530458135305305353053063530751235307513353075143533948435339485353394863533948735357498353574993535774035361258353612593536146035361461353614623536146335362807353628083536503735365038353650393536580035365801353658023536580335365804353658053536755535370836353708373537083835370839353711803537118135371182
36817573; 10. H965SCH647120 UDI-DI 08714729263906 Batches169 of 169 codes
352842143528421635284217352960253529602635296027353075173530953535309536353134333531343435313435353435713537608035376081353760823537608335395628353956293539563035406003354528383547139435471395354713963547139735471398354763503547635135476352354768193547696035514613355414843554148535541486355414873554264435542645355426463554264735588888355888893558889035594003356003803560038135600716356007173560071835663304356633053566330735663958356639593566448035664482356676043574922535749227
36834285; 11. H965SCH647130 UDI-DI 08714729263913 Batches289 of 289 codes
352582693525827035258273352582743526022835260229352655223526552335266396352663973526639835266399352678713526787235272291352722923527368735273688352736893527400135274002352740033527400435276183352761843527618535276186352761873527760935278162352781633527816435278165352781673528132835281329352893053530661035306611353066123531069335310694353106953531069635315986353159873531598835320538353205393532456335324564353245653532456635324567353245683532456935376084353760853537608735380104
36844079; 12. H965SCH647140 UDI-DI 08714729263920 Batches487 of 487 codes
352582753525827635258277352582783525827935260230352602313526161835261619352641883526418935264190352641913526419235266488352664893526864735268648352787463528132635281327352854933528549435285495352854963528549735285498352854993528592035286196352861973528619835286199352865403528731735287319352874013528901535289303352930593529316035293161352931623529316335293812352938133529381535293816353205203532052135320522353205233532052535325953353259543532595535329088353290903532909135329092
36818515; 13. M001719000 UDI-DI 08714729781165 Batches108 of 108 codes
352722893527229035278747352787483529381735293818352938193530970335309704353097053530970635320537353299763532997835329979353416813534168235344559353453213534532935347267353472683534726935383621353866793538678035386781353882763538827735428800354288013542880235428803354844993548952735489530354895333549653435496535354965363552517835530635355602203556022135560222355662313562559135625592356411573564146035677035356770363567703735677038356827863568278735682788356827893568279035682791
UDI-DI 08714729781189 Batches3543865535438656354386573564199335641994360539983605399936223361362233623634820636523368366161273677725614.M001719010
UDI-DI 08714729781202 Batches3525280735307515353075163535553635450114354501153550417935504200355042013557104135583635355836363558363736223363362233643622412936224132362241333623081836297515362975163629751836297761363681413636814236412855364754753653930736616133366161343673920215.M001719020
36767806; 16. M001719030 UDI-DI 08714729781226 Batches65 of 65 codes
352528123534356835343569353435703534357235355537353796613540600235476349354801153548011635542648355602303556023135629995356299963562999735636546356365473566200235662003359614013596140235961403359614043596140535970484359720133597761936006440360076153600761636007618362716623627166336271664362716653627166636275712362757133627571436275715362757163629915036299151362991523629915336299154363067873630678836397121363971223645379136453792364537933645379536475476365523753655237636565457
36635533; 17. M001719040 UDI-DI 08714729781103 Batches3534357335347264353796623547696135476962355456863555030935550605355895323566448335749224359803323598033335997086360180433607842936087098360870993608754036096632360966333634722736397123364164303641643136563911365654583656545936635532
36713869; 18. M001719050 UDI-DI 08714729781127 Batches352813233528132435281325353245703532457135416155354844953554773835623469361138863611388736115281361152823612425936124480361244813616915036209425364983403671173936712757
36817706; 19. M001719060 UDI-DI 08714729781141 Batches352938143529592335347265353472663538827835485560355539393564199135682792359392133593921435939215359392163606552436065525360655263614852936148532365087703660659236771557
353106973531598135315982353472703538827935496537355662343568279335978123360437813610545236159664361596653616484036498342
- 1. H7493915010240 UDI-DI 08714729781097 Batches
- Amount recalled
- 26,570 (1,333 US; 25,174 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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