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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Arrow International Inc: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

Agency Publication Date: June 26, 2020
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Affected Products

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V 160105V through 160109V 160112V through 160118V 160120V 160122V 160126V 160201V through 160209V 160211V 160213V through 160214V 160216V through 160217V 160219V 160312V through 160314V 160316V through 160323V 160325V through 160327V 160331V 160401V through 160410V 160412V 160418V through 160422V 160519V 160525V 160529V through 160530V 160605V 160614V 160618V 160630V 160638V through 160639V 160645V 160703V 160718V 160720V 160726V 160728V through 160730V 170101V through 170110V 170401V through 170410V 170501V through 170520V 170601V through 170625V 170811V through 170830V 171021V through 171030V 171037V through 171046V 171106V through 171115V 180131V through 180150V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V 180411V through 180420V 180441V through 180450V 180521V through 180530V 180621V through 180630V 180711V through 180720V 180741V through 180750V 180811V through 180820V 181011V through 181040V 181111V through 181130V 190121V through 190130V 190141V through 190150V 190211V through 190220V 190411V through 190420V 190431V through 190440V 190531V through 190540V 190701V through 190712V 190737V through 190748V 190813V through 190824V 190837V through 190848V 190913V through 190924V 190937V through 190948V 191001V through 191012V 191025V through 191036V 191101V through 191112V 191137V through 191148V 200113V through 200136V 200314V through 200324V

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

Serial Number Ranges: 150301V 160119V 160429V through 160430V 160634V 160643V

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 150103W through 150105W 150108W through 150109W 150114W 150119W 150202W through 150219W 150303W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W 150310W 150404W through 150406W 150410W 150501W through 150506W 150515W 150606W through 150607W 150612W through 150622W 150701W 150706W 150708W through 150712W 150717W through 150719W 150803W through 150820W 150822W through 150823W 150825W 150913W through 150918W 150924W 150940W 151001W through 151008W 151017W through 151018W 151020W 151028W 151109W 151112W 151115W through 151120W 160104W 160110W through 160111W 160121W 160123W through 160125W 160127W through 160130W 160210W 160212W 160215W 160218W 160220W 160301W through 160304W 160307W through 160311W 160315W 160324W 160328W through 160330W 160332W through 160340W 160411W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 160413W through 160417W 160423W through 160424W 160428W 160501W through 160502W 160504W through 160507W 160520W through 160524W 160526W through 160528W 160601W through 160604W 160606W through 160613W 160615W through 160617W 160620W through 160629W 160632W through 160633W 160701W through 160702W 160704W 160706W through 160713W 160716W through 160717W 160719W 160721W through 160725W 160727W 160734W through 160742W 160744W through 160745W 160801W through 160803W 160805W through 160823W 160825W through 160827W 160829W through 160830W 160901W through 160917W 160920W through 160945W 170201W through 170203W 170207W through 170208W 170211W through 170220W 170222W through 170230W 170301W 170303W through 170307W 170309W through 170327W 170329W through 170330W 170606W through 170610W 170921W through 170927W 170929W through 170930W 170941W through 170950W 171101W through 171104W 171118W 171202W through 171205W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 180111W through 180119W 180302W through 180308W 180310W 180331W through 180332W 180334W through 180340W 180501W through 180510W 180531W through 180540W 180611W through 180620W 180721W through 180730W 180751W through 180760W 180831W through 180839W 180932W through 180938W 180940W through 180941W 181051W through 181053W 181055W 190111W through 190118W 190222W 190227W through 190228W 190230W 190321W through 190330W 190511W 190513W 190515W through 190518W 190520W through 190530W 190621W through 190630W 190634W through 190640W 190849W through 190860W 191043W through 191046W 191048W 200213W through 200236W

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

Serial Number Ranges: AUTOCAT2 WAVE SPANISH IAP-0500E 150302W 150304W 150402W through 150403W 150408W 150514W 150826W 151014W 151107W 151110W 160425W through 160427W 160508W through 160510W 160518W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH IAP-0500E 160631W 160637W 160642W 160644W 160705W 160919W 170204W through 170206W 170221W 170308W 170328W 170928W 171116W 180333W 180840W 180939W 181054W 181056W through 181060W 190229W 190512W 190514W 190519W 190631W through 190633W

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

Serial Number Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

Serial Number Ranges: AUTOCAT2 WAVE JAPANESE IAP-0500J 140866W through 140867W 150117W through 150118W 150120W 150201W 150305W 150307W through 150309W 150623W through 150624W 150713W through 150716W 151114W 151209W 151213W 151219W 160503W 160511W through 160515W 160517W 160635W through 160636W 160640W through 160641W 160731W through 160733W 171105W 171117W 171119W through 171120W 171201W 180120W 180301W

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

Serial Number Ranges: 160714W through 160715W 160918W

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

Serial Number Range: AEROAUTOCAT 2 WAVE IAP-0535 150907W 151030W 151101W 151104W 151106W 160305W through 160306W 160743W 160824W 190119W through 190120W 190221W 190223W through 190226W 191047W

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F 150315F 150318F 150321F 150324F through 150326F 161101F through 161110F 161112F through 161120F 161201F through 161210F 170101F through 170120F 170701F through 170710F 170801F through 170810F 170901F through 170920F 170931F through 170940F 171002F through 171010F 171031F through 171036F 171126F through 171130F 180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F 180201F through 180210F 180311F through 180330F 180401F through 180410F 180421F through 180425F 180431F through 180440F 180511F through 180520F 180601F through 180605F 180701F through 180710F 180801F through 180810F 180821F through 180825F 180922F through 180931F 181041F through 181050F 181101F through 181110F 181201F through 181210F 190101F through 190110F 190131F through 190135F 190201F through 190210F 190231F through 190250F 190301F through 190303F 190305F through 190320F 190331F through 190335F 190401F through 190410F 190421F through 190430F 190441F through 190450F 190501F through 190510F 190541F through 190550F 190601F through 190620F 190641F through 190645F 190713F through 190730F 190801F through 190812F 190826F through 190834F 190901F through 190912F 190925F through 190930F 191013F through 191018F 191037F through 191042F 191049F through 191054F 191113F through 191136F 191201F through 191212F 200101F through 200106F 200137F through 200148F 200201F through 200212F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 200301F through 200306F 200325F through 200326F 200328F through 200339F 200341F through 200348F

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

Serial Number Ranges: AC3 Optimus IABP NA/AJLA IAP-0701 170831F through 170840F 171011F through 171020F 171121F through 171125F 180106F through 180110F 180126F through 180130F 180426F through 180430F 180606F through 180610F 180731F through 180740F 180826F through 180830F 180901F through 180910F 180912F through 180921F 181001F through 181010F 190136F through 190140F 190336F through 190340F 190646F through 190650F 190731F through 190736F 190931F through 190936F 191019F through 191024F 191055F through 191060F 200107F through 200112F 200308F through 200311F

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85684
Status: Resolved
Manufacturer: Arrow International Inc
Manufactured In: United States
Units Affected: 10 products (2123 total)
Agency Last Updated: June 29, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.