{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "198397", "product_res_number": "Z-1231-2023", "event_date_initiated": "2023-02-07", "event_date_posted": "2023-03-06", "recall_status": "Open, Classified", "res_event_number": "91642", "product_code": "DSP", "k_numbers": [ "K181122" ], "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.", "code_info": "Model Number (UDI-DI): D998-00-0800-31 (10607567109053¿), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-00-0800-83 (10607567108407), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414).\n\nAll serial numbers", "firm_fei_number": "3001418283", "recalling_firm": "Datascope Corp.", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "Stephanie Howard\n973-709-7779", "reason_for_recall": "Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.", "root_cause_description": "Equipment maintenance", "action": "Firm notified customers on February 7, 2023, in an Urgent Medical Device Correction letter which discussed four issues in total - this issue was Issue #4.\n\nCustomers were instructed to contact their Datascope/Getinge service representative if they observe any visual damage to the O-ring installed as part of the quick disconnect fitting.\n\nDatascope/Getinge is currently updating the annual Preventive Maintenance instruction to include replacement of the quick disconnect fitting O-ring. \n\nIf you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). \n\nOn 11/04/2025 the recall was expanded, and consignees were notified via letter. The\nnotification was for awareness to the update of Datascope s preventative maintenance in the IFU addendum, which was provided to consignees. The IFU Addendum contains an updated Schedule B Preventive Maintenance Schedule which calls for the Quick Disconnect Fitting O-Ring to be replaced and to lubricate the console release latch every 12 months or 2500 hours. The Service Manual has contained this update to Preventive Maintenance for\nthe Helium O-Ring since June 2023. Consignees were instructed to review the IFU Addendum and local Preventive Maintenance Schedule and update their Preventive Maintenance schedule accordingly.", "product_quantity": "11,792 units (5.408 US, 6,384 OUS)", "distribution_pattern": "Nationwide US distribution. Worldwide international distribution.", "openfda": { "k_number": [ "K894942", "K864994", "K813355", "K940178", "K963104", "K915580", "K002256", "K971673", "K935184", "K122628", "K925248", "K190101", "K813182", "K922235", "K892799", "K952576", "K980780", "K790241", "K882274", "K921638", "K811372", "K982538", "K003598", "K133074", "K192238", "K820882", "K000729", "K082746", "K853062", "K892878", "K860427", "K833632", "K770821", "K031636", "K972113", "K823739", "K903893", "K944460", "K911000", "K893243", "K950687", "K875036", "K830411", "K250542", "K932268", "K974247", "K952221", "K942454", "K914802", "K963865", "K040801", "K863185", "K781848", "K904414", "K924382", "K091449", "K790755", "K010330", "K832753", "K905313", "K831307", "K945230", "K232343", "K790775", "K892798", "K961509", "K190117", "K002949", "K983866", "K905663", "K802167", "K892222", "K981660", "K960713", "K172305", "K820166", "K802924", "K994157", "K831235", "K860638", "K844220", "K151254", "K961358", "K903867", "K850482", "K963187", "K162820", "K903736", "K965236", "K830410", "K910997", "K980385", "K903344", "K904018", "K905056", "K163542", "K912629", "K940298", "K200634", "K980850", "K864568", "K896430", "K896920", "K926000", "K823177", "K903917", "K801601", "K063525", "K892797", "K903892", "K874816", "K943919", "K020257", "K120868", "K823342", "K954431", "K112372", "K962177", "K062582", "K021462", "K882508", "K896497", "K993966", "K013326", "K831397", "K900281", "K813023", "K902057", "K060309", "K895433", "K112327", "K864537", "K864567", "K960166", "K181122", "K913847", "K855102", "K903769", "K070225", "K833828", "K041281", "K903930", "K970689", "K810297", "K821065", "K201112", "K780280", "K840037", "K840367", "K920427", "K863219", "K964987", "K973962", "K965209", "K896597", "K963920", "K821951", "K940231", "K031569", "K880289", "K760695", "K936232" ], "registration_number": [ "9681477", "2518435", "3007965489", "3010532612", "1319639", "2011171", "2249723", "3013500228", "3013596024", "3002807314", "2248146", "3010041511", "3013320573", "2183744", "1061124", "3009077524", "3024894463", "2031093", "2032677", "3000126629", "3010155661", "9610816", "3008496839", "9680794", "3013162291", "3015859709", "2126666", "3003263092" ], "fei_number": [ "2518435", "3007965489", "3010532612", "1000138054", "2011171", "1000222374", "3013500228", "3013596024", "3002807314", "3003945344", "3001236549", "3010041511", "3013320573", "2183744", "3009077524", "3024894463", "1000512168", "3001418283", "3000126629", "3010155661", "3002807167", "3008496839", "3013162291", "3002807439", "3003737899", "3015859709", "2126666", "3003263092" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }