{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196525", "product_res_number": "Z-0429-2023", "event_date_initiated": "2022-10-17", "event_date_posted": "2022-12-15", "recall_status": "Open, Classified", "res_event_number": "91021", "product_code": "DSP", "k_numbers": [ "K060309" ], "product_description": "Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump", "code_info": "UDI/DI (01) 0 0801902 05171 4, (01) 0 0801902 05171 5, All Lot/Serial Numbers", "firm_fei_number": "3013162291", "recalling_firm": "ARROW INTERNATIONAL Inc.", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "additional_info_contact": "Customer Service\n866-396-2111", "reason_for_recall": "There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.", "root_cause_description": "Pending", "action": "The firm issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 10/17/2022 by FedEx 2-day mail. To reduce the risk of short battery run time:\n .Plug IABP into an AC outlet during patient use, and when not in use.\n .Ensure the battery is fully charged prior to transporting patients, and a fully charged backup IABP device is available.\n .Replace the batteries when Battery Run Time is less than 90 minutes, there is visual damage to the battery, or Battery has been in service for 3 years. \n . Perform Battery Load Test at least every 12 months by qualified service personnel. If there is an issue with the battery load, immediately quarantine the device and contact Teleflex Customer Service to report the issue and receive service support for the affected IABP device. \n If a battery load test has not been performed in the past 12 months, perform battery load test prior to transporting patients with affected IABP devices. \n .If the IABP device battery fails while in use, immediately connect to an AC power source to continue therapy. \n .If a source of AC power is not available, transfer the patient to a fully charged back-up IABP device. \n .If pumping cannot be restored within 15 to 30 minutes, manually inflate and deflate the IAB several times per hour to reduce the risk of thrombus formation and consider removing the balloon. \nFacility Actions:\n Send a copy of this notification to all relevant personnel in your organization. \n Place a copy of this Notice with all affected products. \nImmediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABP,\nwhether stored or in use.\nReturn the Acknowledgement Form to Teleflex Customer Service. Hours of operation are 8am-7pm EST. Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: Recalls@teleflex.com.", "product_quantity": "2678 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K002949", "K063525", "K112372", "K936232", "K840037", "K830410", "K972113", "K781848", "K994157", "K151254", "K120868", "K813023", "K940178", "K875036", "K820882", "K013326", "K910997", "K821951", "K850482", "K853062", "K894942", "K840367", "K896597", "K031636", "K060309", "K903736", "K945230", "K770821", "K163542", "K882508", "K904018", "K000729", "K932268", "K950687", "K904414", "K801601", "K192238", "K905056", "K832753", "K911000", "K981660", "K920427", "K844220", "K864568", "K896497", "K903867", "K963920", "K903344", "K790241", "K780280", "K201112", "K823177", "K940298", "K830411", "K833828", "K831235", "K921638", "K892799", "K864567", "K912629", "K892222", "K002256", "K973962", "K232343", "K831307", "K980780", "K935184", "K813355", "K963104", "K821065", "K041281", "K200634", "K903892", "K882274", "K926000", "K802924", "K952576", "K971673", "K895433", "K070225", "K863219", "K863185", "K020257", "K942454", "K960166", "K960713", "K813182", "K021462", "K003598", "K914802", "K790755", "K190101", "K820166", "K905663", "K823342", "K924382", "K831397", "K983866", "K790775", "K925248", "K880289", "K896920", "K864537", "K962177", "K122628", "K980850", "K172305", "K974247", "K760695", "K944460", "K864994", "K943919", "K903893", "K903917", "K874816", "K823739", "K902057", "K860427", "K091449", "K970689", "K250542", "K892798", "K893243", "K922235", "K162820", "K181122", "K952221", "K915580", "K811372", "K903930", "K964987", "K993966", "K802167", "K190117", "K965209", "K982538", "K963187", "K900281", "K112327", "K965236", "K905313", "K892797", "K031569", "K980385", "K860638", "K896430", "K963865", "K892878", "K082746", "K940231", "K062582", "K954431", "K133074", "K810297", "K903769", "K040801", "K913847", "K833632", "K010330", "K961358", "K855102", "K961509" ], "registration_number": [ "3002807314", "9610816", "2032677", "3024894463", "3010155661", "3009077524", "2126666", "3015859709", "3013162291", "2011171", "2248146", "1061124", "3007965489", "9681477", "2031093", "3003263092", "3010041511", "3008496839", "3013320573", "3013596024", "1319639", "2183744", "2249723", "9680794", "3013500228", "2518435", "3000126629", "3010532612" ], "fei_number": [ "3002807314", "3024894463", "3010155661", "1000138054", "1000222374", "3009077524", "2126666", "3015859709", "3013162291", "2011171", "3002807439", "3007965489", "3001418283", "3001236549", "3003263092", "3010041511", "3008496839", "1000512168", "3013320573", "3013596024", "2183744", "3003737899", "3003945344", "3013500228", "2518435", "3000126629", "3002807167", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }