{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189166", "product_res_number": "Z-0076-2022", "event_date_initiated": "2021-09-08", "event_date_posted": "2021-10-07", "recall_status": "Open, Classified", "res_event_number": "88651", "product_code": "DSP", "k_numbers": [ "K181122" ], "product_description": "Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85", "code_info": "All lots", "firm_fei_number": "3001418283", "recalling_firm": "Datascope Corp.", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "Marylou Insinga\n201-995-8701", "reason_for_recall": "The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.", "root_cause_description": "Device Design", "action": "On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue experience the following issue: Helium Indicator Inaccuracy in the Presence of Continuous EMC Disturbances.\n\nCustomers were provided with actions to take to limit the possibility of loss of therapy due to an over-reporting of remaining helium on the Helium Indicator.\n\nCardiosave Hybrid users should view the mechanical gauge on the Cardiosave Top Panel to assess remaining helium capacity in case of suspected EMC disturbances.\n\nCardiosave Rescue users should ensure the internal helium reservoir is full prior to use of the device. If the on-screen helium indicator is not showing full, fill the internal helium reservoir via the hospital cart or Helium Refilling Station. Please review the Cardiosave IABP Operation Transport\nQuick Reference Guide (0002-08-9772) for details on using the Cardiosave Rescue in\ntransport.\n\nFor both devices: Where practical maximize separation of Cardiosave system from other electronic equipment,\ncommunication devices and cables (e.g. power and communication cables). In particular,\nfollow the recommended separation distances between communications equipment and the\nCardiosave equipment as specified in the Cardiosave Operating instructions manual. \n\nThe firm is developing a hardware correction to address this issue. A Datascope/Getinge service representative will contact customers to schedule the installation of the correction when available. The correction approximately will begin late Q2 2022.\n\nIf you have\nany questions, please contact your Datascope/Getinge representative or call the\nDatascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through\nFriday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "product_quantity": "5054 total (US); 5033 total (OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide distribution.", "openfda": { "k_number": [ "K063525", "K904414", "K892798", "K965209", "K003598", "K112327", "K900281", "K250542", "K790775", "K896430", "K201112", "K943919", "K122628", "K002949", "K902057", "K932268", "K120868", "K914802", "K813023", "K031569", "K830411", "K913847", "K896597", "K010330", "K760695", "K850482", "K963104", "K832753", "K882274", "K112372", "K982538", "K060309", "K031636", "K831307", "K831397", "K926000", "K905313", "K960166", "K770821", "K925248", "K041281", "K820882", "K190117", "K942454", "K994157", "K963865", "K831235", "K813355", "K952221", "K021462", "K070225", "K875036", "K980850", "K922235", "K973962", "K813182", "K903930", "K905056", "K780280", "K892797", "K912629", "K962177", "K863219", "K903736", "K963187", "K915580", "K921638", "K880289", "K971673", "K232343", "K874816", "K983866", "K960713", "K823342", "K940298", "K020257", "K954431", "K892222", "K903892", "K190101", "K013326", "K864537", "K936232", "K882508", "K163542", "K151254", "K894942", "K940178", "K911000", "K162820", "K974247", "K981660", "K896920", "K864568", "K000729", "K082746", "K781848", "K961358", "K833632", "K823177", "K920427", "K830410", "K904018", "K853062", "K905663", "K860638", "K821065", "K040801", "K924382", "K892799", "K200634", "K903867", "K964987", "K965236", "K972113", "K181122", "K002256", "K895433", "K903769", "K820166", "K790241", "K980385", "K961509", "K810297", "K903917", "K844220", "K821951", "K940231", "K980780", "K944460", "K903893", "K903344", "K802924", "K896497", "K833828", "K864994", "K952576", "K802167", "K790755", "K840037", "K963920", "K893243", "K855102", "K935184", "K892878", "K172305", "K950687", "K801601", "K062582", "K840367", "K091449", "K860427", "K910997", "K945230", "K970689", "K133074", "K192238", "K993966", "K811372", "K863185", "K823739", "K864567" ], "registration_number": [ "9681477", "9680794", "2249723", "3013500228", "1319639", "3009077524", "2032677", "3002807314", "3015859709", "2183744", "3013162291", "9610816", "1061124", "2518435", "3003263092", "3008496839", "3000126629", "3013320573", "3024894463", "2126666", "3007965489", "2011171", "3010155661", "2248146", "3010041511", "3013596024", "2031093", "3010532612" ], "fei_number": [ "3001418283", "3013500228", "3002807167", "3009077524", "3002807314", "3015859709", "2183744", "3001236549", "3013162291", "2518435", "3003263092", "1000222374", "3008496839", "3000126629", "3013320573", "1000512168", "3024894463", "1000138054", "2126666", "3007965489", "3002807439", "2011171", "3010155661", "3003945344", "3010041511", "3013596024", "3003737899", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }