Device Recall AutoCAT 2 Series Intra

  • Model / Serial
    Serial Numbers: 070405V, 070411V, 070412V, 070413V, 070415V, 070416V, 070420V, 070421V, 070422V, 070423W, 070424V, 070426V, 070501V, 070502W, 070503W, 070510V, 070512W, 070513V, 070514W, 070518V, 070520W, 070522W, 070523W, 070524V, 070525W, 070526V, 070527V, 070528W, 070529V, 070530W, 070531W, 070532W, 070533W, 070534W, 070535W, 070536W, 070537V, 070538V, 070539V, 070540W, 070601W, 070602W, 070603V, 070604V, 070605W, 070606W, 070607W, 70608W, 070609W, 070610W, 070611W, 070612W, 070613W, 070614W, 070615W, 070616W, 070617W, 070618W, 070619W, 70620W, 070621W, 070622W, 070623W, 070624W, 070625W, 070626W, 070627W, 70628W, 070629W, 070630W, 070631W, 070632W, 070633W, 070634W, 070635W, 070636W, 070637W, 070638W, 070639W, 070640W, 070641W, 070642W, 070643W, 070644V, 070645W, 070646V, 070647V, 070648V, 070649W, 070650V, 31122V, 41146W, 51007W, 60930W, 60939W, 70111W, 70112W, 70113V, 70114W, 70115W, 70116V, 70117W, 70118W, 70119W, 70120W, 70121W, 70122W, 70123W, 70124V, 70125W, 70126V, 70127W, 70128V, 70129W, 70130W, 70131W, 70132W, 70133W, 70134W, 70135W, 70136W, 70137W, 70138W, 70139W, 70140W, 70141V, 70142W, 70143W, 70144W, 70145W, 70146W, 70147W, 70148W, 70149W, 70150W, 70201W,70202W, 70203W, 70204W, 70205W, 70206W, 70207W, 70208W, 70209W, 70210W, 70211W, 70212W, 70213W, 70214W, 70215W, 70216W, 70217W, 70218W, 70219W, 70220W, 70221V, 70222V, 70223W, 70224V, 70225W, 70226V, 70227W, 70228W, 70229V, 70230V, 70231W, 70232V, 70233W, 70234V, 70235V, 70236V, 70237W, 70238W, 70239W, 70240W, 70301W, 70302W, 70303W, 70304W, 70305W, 70306W, 70307W, 70308W, 70309W, 70310W, 70311W, 70312V, 70313W, 70314W, 70315V, 70316W, 70317W, 70318W, 70319V, 70320W, 70401W, 70402W, 70403W, 70404W, 70406W, 70407W, 70408W, 70409W, 70410W, 70414W, 70417W, 70418W, 70419W, 70425W, 70427W, 70428W, 70429W, 70430W, 70504W, 70505W, 70506V, 70507W, 70508W, 70509W, 70511W, 70515W, 70516W, 70517W, 70519W, and 70521V
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey.
  • Product Description
    AutoCAT 2 Series Intra-Aortic Balloon Pumps || Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
  • Source
    USFDA