Z-0550-2008

AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow...

Name: Z-0550-2008 AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow...
Creator: Arrow International Inc
Published: 2007-11-12
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2007-11-12 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149 on 2007-11-12. The reason FDA records is "Leak may occur in the helium drive system for the IABP". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0550-2008
Status: Terminated
Initiated: 2007-11-12
Posted: 2008-01-25
Terminated: 2010-01-11
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Leak may occur in the helium drive system for the IABP
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative.
Quantity in commerce: 225 units
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 codes and lots: 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 code DSP

K060309Class IIAutocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. / cleared 2006-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)