Reported Nov 9, 2022 · Ongoing
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Fogarty Arterial
- Embolectomy Catheters Model NumberFogarty Arterial Embolectomy
120602FP120403FP120803FP120404FP120804FP120805FP120806FP120807FP
- Catheter with Stylet Model Number120403FSP 120803FSP
- Lot codes and dates
- Fogarty Arterial 120403FP Embolectomy
- Catheters Model Number / UDI-DI Code120602FP / 00690103205206
- Lot Numbers/ 00690103205084
157 of 157 codes
633258176341299064049166640524166432046864311217642860416407555664085285641248896418061963914203639679606326627563281593634496456356063063612077636269266373886063735762637503046377296863724845639142016389200763967950639900506402788164036551640524156406348764124888641736696418062064180548643325056434474263907174640990106409900863420190634356036347615963511721636005086361174263669399637503036373581863850952639071756394442963984736639444676390716764014108639957016403669864075555
- Lot Numbers/ 00690103205091
87 of 87 codes
632815946342019263293457632923026343560563227617632662766385102064180623640633996418062164173655643494866427443163735809636005136361173563611730636121456361214863612150637503066385101963967943640491556408538964205542634129966364647763626918638510136407558064286055634496466352306963801880642208446352590263669388632438606329229963243604635085586351155563611731636005106361173463554739636005116360051263614211636121446361214963626919637248256372482763735752637358106377297263851016
- Lot Numbers/ 00690103205107
225 of 225 codes
632816156330186663293544634496516328161663540578640141166403655064085388641736626418062864239085641931896422863164311235642318156406348864180563641806276367004763883800639143746389204763990053643682716434948963883785638837876399871064017928642319826419318164231983642527436429782263281612632662796330418763266281632662826338686463501940636121576366102463751152637511536375115563776326639900446399004564075767641106806431124163669391636771696367005063735803636700496385102563851026
- Lot Numbers/ 00690103205213
123 of 123 codes
633162436326618263412917634475316338678663431368634496096326618363464776640491636405243664193102642690696409803764297683640523436410263864075502641805806405243864180581642898246326618463776293637793136371231863744071638832956388329863891423639679406408522964098969638832976395432864036656641804976337523563266187633752336352303263669373636693726366937563669450636770106388329363954330639986306399864964075503635230316367056763850871638509446401403264098970633752346332572163325722
- Lot Numbers/ 00690103205220
251 of 251 codes
633497746334977563158527634496176350208963349776634129306342012863435526637078816403654064036679640491646408523264180590641736406425268964252690642744106428599564285992643209826403653864205460643111896406347464075525640852446417363964180587641805016418058663669378639444706391432363914324639986186394442563944464640277876401403463998619637762846373581663914300639956816402778563998650633162556331074563301457633162566334977763408651633401956351866563626923636332616366996863669974
- Lot Numbers/ 00690103205237
159 of 159 codes
633257406343189963412921639956806399860864014033642859996428599764231795642389606406348264098984640633606417364764231724642054656420546464052348641106226371234063852652638509456394441964344670639187986389143063984701639444206399864063995682639543316342014163292125633645376336453963386792634355286344961963518673634201426345623363669382636699846373881563687368637502836378960163944462639679556406348364110624641931256373881663755559639986136343553163435530634759636348151663518668
- Lot Numbers/ 00690103201789
99 of 99 codes
633575946335759363420147640633646417364864180591640140356420546764063363640989916420546664231980643446766371234263850874639137206399864164231805638833266388332564354898632921296329212763431914634201466368737263431920638833226394442863998607642744156432099663944466632921286341292363626929636770156375028763755566638509476388332863856364638833236407577264075783641248616423896964291999642976916338679363735817638526786399865664036546642389676366938563669987636699886395433364238970
- Lot NumbersFogarty Arterial Embolectomy Catheter
633581776401402964085236640989896427442264173650640523446409899064442107636770176368737063967936639986426388333063883329632921336341292463883331639986026404915064063365642054686423180663755565637357486412486264231807642744216385092664036677640755326422081963364535634319336419313663301763633867986343193163449620636117276361252063634654636269036367701863724815637123456385636563944458639543376399568564085237642860116429769264320999642744236443733964344678
- with Stylet Models Number / UDI-DI Code120403FSP / 00690103205190
- Lot Numbers/ 00690103205244
6328161363292303634564576406340063281617632816186385102263435606638563796396794863990055638920446401411864075582639679536391420564124895640141196372482864173656641736576418062464248137643682696385638064085390634496546336460364220845120803FSP
- Lot Numbers
93 of 93 codes
632923066331645063325827633258286336460463851032639143666391421163975628640990166411068364205557642286386428076563266285633164516335790363420194634201956342019663316452634564756345649663456472634201936345649763720572633498216343561163687388637248376373563463735633637356356373576363735755637358136377632763851029638510306388380163851028638510276393059163945551639320616388380963892049639142106393059263944463639543996398473463944469640257996402580063984735639957126401412064014117
- Amount recalled
- 715,620 units
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
Why it was recalled
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
This product could cause temporary or reversible health problems — stop using it.
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.
Free recall alerts
Get alerted about new Edwards Lifesciences, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.