AutoCAT 2 Series Intra-Aortic Balloon Pumps recallZ-0550-2008 · Arrow International Inc · initiated Nov 12, 2007
Terminated All recalls posted in January 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leak may occur in the helium drive system for the IABP
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0550-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 12, 2007
- Posted by the FDA
- Jan 25, 2008
- Recalling firm
- Arrow International Inc
- Quantity
- 225 units
- Product code
- DSP
- FDA submissions
- K060309
- 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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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
Other devices under the same FDA submission
11 devices cleared under K060309 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN000320Teleflex Incorporated · System, balloon, intra-aortic and control2 deaths383 reports
- ARROW IPN000302Teleflex Incorporated · System, balloon, intra-aortic and control54 reports
- ARROW IPN000325Teleflex Incorporated · System, balloon, intra-aortic and control44 reports
- ARROW IPN000324Teleflex Incorporated · System, balloon, intra-aortic and control14 reports
- ARROW IPN000329Teleflex Incorporated · System, balloon, intra-aortic and control8 reports
- ARROW IPN000308Teleflex Incorporated · System, balloon, intra-aortic and control1 report
- ARROW IPN000312Teleflex Incorporated · System, balloon, intra-aortic and control1 report
- ARROW IPN000333Teleflex Incorporated · System, balloon, intra-aortic and control1 report
- ARROW IPN000334Teleflex Incorporated · System, balloon, intra-aortic and control1 report
- ARROW IPN000323Teleflex Incorporated · System, balloon, intra-aortic and control1 report
- ARROW IPN000328Teleflex Incorporated · System, balloon, intra-aortic and control1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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