{ "meta": { "disclaimer": "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "95065", "product_res_number": "Z-0790-2011", "event_date_initiated": "2010-10-11", "event_date_posted": "2010-12-23", "recall_status": "Terminated", "event_date_terminated": "2015-02-05", "res_event_number": "56965", "product_code": "DSP", "k_numbers": [ "K000729", "K021462" ], "product_description": "Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc.\nModel: IAB-05830-U", "code_info": "Lot Numbers: KF0087756 MF0053016 MF0053017 MF0053018 MF0053019 MF0073778 MF0074136 MF0074137 MF5114292 MF7076257 MF7118004 MF7128505 MF8103263 MF8124064 MF8124178 MF8124307 MF8124408 MF9014573 MF9025207 MF9025208 MF9025213 MF9025226 MF9025227 MF9035382 MF9035448 MF9046246 MF9056839 MF9056840 MF9057065 MF9057066 MF9067735 MF9067736 MF9077955 MF9077968 MF9077969 MF9078203 MF9078343 MF9088501 MF9099356 MF9099357 MF9099358 MF9099359 MF9110054 MS9056710 MS9057152 MS9057153 MS9109664 MS9110295 MS9110368", "firm_fei_number": "3010532612", "recalling_firm": "Arrow International, Inc., Division of Teleflex Medical Inc.", "address_1": "9 Plymouth St", "city": "Everett", "state": "MA", "postal_code": "02149-1814", "additional_info_contact": "SAME\n617-389-6400", "reason_for_recall": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "root_cause_description": "Device Design", "action": "Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.", "product_quantity": "5289 units", "distribution_pattern": "Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.", "openfda": { "k_number": [ "K963865", "K163542", "K905313", "K965236", "K943919", "K790755", "K993966", "K903893", "K823177", "K810297", "K003598", "K840037", "K200634", "K892799", "K940298", "K840367", "K925248", "K942454", "K895433", "K896430", "K964987", "K920427", "K940231", "K770821", "K831397", "K903736", "K112327", "K830410", "K980780", "K833828", "K801601", "K192238", "K980385", "K020257", "K974247", "K863219", "K935184", "K972113", "K963104", "K060309", "K122628", "K903892", "K760695", "K190117", "K903917", "K915580", "K820882", "K892878", "K983866", "K864568", "K900281", "K063525", "K013326", "K963187", "K954431", "K945230", "K896597", "K190101", "K082746", "K031636", "K010330", "K960166", "K994157", "K896497", "K844220", "K181122", "K864994", "K813023", "K952576", "K922235", "K002949", "K880289", "K790775", "K905056", "K882508", "K926000", "K903930", "K850482", "K973962", "K864567", "K802924", "K903769", "K091449", "K133074", "K781848", "K892798", "K903867", "K040801", "K201112", "K112372", "K860638", "K151254", "K981660", "K860427", "K921638", "K833632", "K904414", "K910997", "K904018", "K811372", "K892222", "K932268", "K863185", "K961358", "K913847", "K790241", "K062582", "K823739", "K936232", "K855102", "K864537", "K162820", "K882274", "K802167", "K820166", "K912629", "K970689", "K924382", "K853062", "K875036", "K232343", "K120868", "K831235", "K892797", "K965209", "K896920", "K962177", "K905663", "K960713", "K821951", "K961509", "K944460", "K041281", "K813355", "K963920", "K831307", "K830411", "K914802", "K971673", "K031569", "K000729", "K893243", "K021462", "K952221", "K902057", "K894942", "K982538", "K940178", "K950687", "K813182", "K823342", "K821065", "K780280", "K250542", "K911000", "K903344", "K070225", "K874816", "K832753", "K980850", "K172305", "K002256" ], "registration_number": [ "3015859709", "2248146", "2011171", "9610816", "3010155661", "3000126629", "3003263092", "3013500228", "3024894463", "3013162291", "3013320573", "2183744", "1319639", "9681477", "2031093", "3008496839", "3013596024", "2518435", "2249723", "9680794", "3002807314", "3010041511", "3009077524", "2032677", "2126666", "1061124", "3007965489", "3010532612" ], "fei_number": [ "3015859709", "1000138054", "2011171", "3010155661", "3001236549", "3000126629", "3003263092", "3013500228", "3024894463", "3001418283", "3003945344", "1000222374", "3002807439", "3013162291", "3013320573", "2183744", "3008496839", "3013596024", "3003737899", "1000512168", "2518435", "3002807314", "3010041511", "3009077524", "2126666", "3007965489", "3002807167", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }