{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "189203", "product_res_number": "Z-2615-2021", "event_date_initiated": "2021-09-08", "event_date_created": "2021-09-30", "recall_status": "Open, Classified", "res_event_number": "88664", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K163542" ], "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65", "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 Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is\ninstalled in the IABP, and the battery is physically removed while the battery is being charged. This occurs during\na very specific set of conditions.", "root_cause_description": "Software 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 experience the following issue: Unexpected\nShutdown Upon\nBattery Removal. \n\nImmediate Actions to be taken by Customers:\nTo ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when:\n\n- There is a singulat battery in either battery charging bay and unused battery bay is empty.\n- The battery is charging on AC power (indicated by a flashing LED on the battery pack).\n\n\nAdditionally, the user can prevent the issue by ensuring that a battery is inserted into each of\nthe two battery bays. Should a charging battery be ejected inadvertently, the unit will\nautomatically switch over to the second battery, thus preventing system shutdown.\nFurthermore, Datascope/Getinge is developing a software correction to address this issue. A\nDatascope/Getinge service representative will contact you to schedule the installation of the\nupdated software. This work will be done at no cost to your facility.\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": "3969 total (US), 3550 total (OUS)", "distribution_pattern": "Nationwide domestic distribution. Foreign distribution worldwide.", "openfda": { "k_number": [ "K810297", "K811372", "K181122", "K892799", "K020257", "K961358", "K770821", "K832753", "K112372", "K894942", "K896597", "K963104", "K823739", "K831307", "K893243", "K863185", "K860427", "K980780", "K070225", "K840367", "K840037", "K963920", "K970689", "K780280", "K031636", "K981660", "K914802", "K993966", "K002949", "K932268", "K062582", "K855102", "K010330", "K813182", "K896430", "K880289", "K963187", "K905663", "K830411", "K190117", "K863219", "K882508", "K120868", "K903769", "K924382", "K853062", "K936232", "K813355", "K903893", "K943919", "K813023", "K952576", "K864568", "K790755", "K974247", "K133074", "K973962", "K903892", "K112327", "K960713", "K945230", "K950687", "K844220", "K820166", "K833828", "K896497", "K864994", "K031569", "K801601", "K994157", "K940178", "K021462", "K903736", "K954431", "K892797", "K232343", "K860638", "K962177", "K903867", "K972113", "K900281", "K041281", "K831397", "K971673", "K192238", "K920427", "K892798", "K903930", "K790775", "K864567", "K013326", "K942454", "K002256", "K922235", "K892878", "K963865", "K201112", "K874816", "K910997", "K982538", "K082746", "K831235", "K821065", "K895433", "K915580", "K122628", "K940231", "K833632", "K940298", "K905056", "K882274", "K926000", "K040801", "K864537", "K875036", "K903917", "K965209", "K190101", "K781848", "K162820", "K892222", "K925248", "K200634", "K172305", "K823342", "K902057", "K820882", "K921638", "K903344", "K965236", "K063525", "K850482", "K802924", "K802167", "K821951", "K830410", "K060309", "K913847", "K983866", "K823177", "K905313", "K911000", "K091449", "K952221", "K960166", "K003598", "K980850", "K964987", "K790241", "K980385", "K896920", "K250542", "K935184", "K151254", "K163542", "K904018", "K904414", "K944460", "K000729", "K961509", "K912629", "K760695" ], "registration_number": [ "3008496839", "2032677", "3009077524", "3013596024", "2183744", "2249723", "3002807314", "2518435", "9681477", "2031093", "2126666", "1319639", "3010041511", "3010532612", "3013320573", "3024894463", "3015859709", "3000126629", "2248146", "3007965489", "3013162291", "1061124", "9610816", "9680794", "3003263092", "3013500228", "3010155661", "2011171" ], "fei_number": [ "3008496839", "1000512168", "3009077524", "1000138054", "3013596024", "2183744", "3003945344", "3002807314", "2518435", "2126666", "3010041511", "3010532612", "3002807439", "3013320573", "3024894463", "3015859709", "3000126629", "1000222374", "3001236549", "3007965489", "3013162291", "3001418283", "3003263092", "3013500228", "3003737899", "3010155661", "2011171", "3002807167" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }