{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217318", "product_res_number": "Z-0931-2026", "event_date_initiated": "2025-10-23", "event_date_posted": "2025-12-16", "recall_status": "Open, Classified", "res_event_number": "97956", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K163542", "K181122" ], "product_description": "Cardiosave Hybrid", "code_info": "1) Model: 0998-00-0800-31;\nUDI-DI: 10607567109053;\nSerial Numbers: All;\n\n2) Model: 0998-00-0800-32;\nUDI-DI: 10607567111117;\nSerial Numbers: All;\n\n3) Model: 0998-00-0800-33;\nUDI-DI: 10607567109008;\nSerial Numbers: All;\n\n4)Model: 0998-00-0800-35;\nUDI-DI: 10607567109107;\nSerial Numbers: All;\n\n5)Model: 0998-00-0800-36;\nUDI-DI: 10607567114187;\nSerial Numbers: All;\n\n6)Model: 0998-00-0800-45;\nUDI-DI: 10607567108421;\nSerial Numbers: All;\n\n7)Model: 0998-00-0800-52;\nUDI-DI: 10607567108438;\nSerial Numbers: All;\n\n8)Model: 0998-00-0800-53;\nUDI-DI: 10607567108391;\nSerial Numbers: All;\n\n9) Model: 0998-00-0800-55;\nUDI-DI: 10607567108414;\nSerial Numbers: All;\n\n10) Model: 0998-00-0800-65;\nUDI-DI: 10607567113432;\nSerial Numbers: All;\n\n11) Model: 0998-UC-0800-31;\nUDI-DI: 10607567109053;\nSerial Numbers: All;\n\n12) Model: 0998-UC-0800-33;\nUDI-DI: 10607567109008;\nSerial Numbers: All;\n\n13) Model: 0998-UC-0800-52;\nUDI-DI: 10607567108438;\nSerial Numbers: All;\n\n14) Model: 0998-UC-0800-53;\nUDI-DI: 10607567108391;\nSerial Numbers: All;\n\n15) Model: 0998-UC-0800-55;\nUDI-DI: 10607567108414;\nSerial Numbers: All;", "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\n201-995-8701", "reason_for_recall": "The IFU addendum updates the Vibration and Shock Table to reference the correct standards.", "root_cause_description": "Process change control", "action": "On November 4, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Review the IFU Addendum. An IFU Addendum was created to reference the appropriate Transportation Standards that were tested\nin product specifications. Please forward\nthis information to all current and potential Cardiosave IABP users within your facility. Complete and\nsign the attached Response Form to acknowledge that you have received and understand this\nnotification. Return the completed form to recallresponses.qrc@getinge.com.\nIf you are a distributor who has shipped any affected products to customers, please forward this\ndocument to their attention for appropriate action.\nActions to be taken by Datascope:\nDatascope created an IFU Addendum with a clarification to the Vibration and\nShock Table IFU information. If you require a physical copy, please contact your local Datascope/Getinge representative, and one will\nbe provided to you at no cost.\nWe apologize for any inconvenience this correction may cause. If you have any questions, please call\nDatascope/Getinge Customer Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday,\nbetween the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "product_quantity": "11470 units (5095 US, 6375 OUS)", "distribution_pattern": "Domestic: Nationwide distribution.\n\nInternational: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;", "openfda": { "k_number": [ "K810297", "K002949", "K070225", "K952221", "K112372", "K192238", "K940231", "K982538", "K944460", "K972113", "K863185", "K831235", "K981660", "K820166", "K790241", "K915580", "K950687", "K914802", "K133074", "K041281", "K896497", "K954431", "K994157", "K882508", "K903769", "K840367", "K903892", "K903917", "K860427", "K903344", "K802924", "K010330", "K893243", "K122628", "K903867", "K864568", "K770821", "K961509", "K163542", "K904018", "K932268", "K912629", "K874816", "K813023", "K831397", "K181122", "K921638", "K892797", "K250542", "K894942", "K892799", "K190101", "K850482", "K943919", "K151254", "K840037", "K760695", "K963187", "K910997", "K905313", "K830411", "K082746", "K200634", "K882274", "K855102", "K974247", "K864994", "K942454", "K920427", "K112327", "K961358", "K020257", "K821951", "K831307", "K031636", "K983866", "K091449", "K965209", "K896597", "K801601", "K980385", "K060309", "K021462", "K830410", "K172305", "K002256", "K940178", "K971673", "K811372", "K892222", "K960713", "K965236", "K980780", "K232343", "K863219", "K821065", "K945230", "K003598", "K892878", "K031569", "K833828", "K963865", "K781848", "K900281", "K875036", "K802167", "K000729", "K962177", "K780280", "K903930", "K063525", "K864537", "K820882", "K823177", "K952576", "K905056", "K832753", "K040801", "K935184", "K813182", "K970689", "K963920", "K880289", "K790755", "K120868", "K905663", "K903736", "K960166", "K013326", "K902057", "K973962", "K924382", "K844220", "K201112", "K925248", "K833632", "K940298", "K823342", "K823739", "K903893", "K896430", "K860638", "K922235", "K963104", "K062582", "K896920", "K892798", "K864567", "K813355", "K980850", "K904414", "K190117", "K162820", "K936232", "K964987", "K895433", "K911000", "K913847", "K926000", "K993966", "K790775", "K853062" ], "registration_number": [ "3013500228", "2248146", "3002807314", "3009077524", "3015859709", "3024894463", "1061124", "3010532612", "3013162291", "2031093", "2518435", "1319639", "3013596024", "9681477", "2249723", "3008496839", "2126666", "3007965489", "2032677", "3010041511", "9610816", "9680794", "3010155661", "3013320573", "3000126629", "2011171", "2183744", "3003263092" ], "fei_number": [ "3013500228", "3002807314", "3009077524", "3015859709", "3024894463", "3003945344", "1000138054", "3010532612", "3013162291", "3001418283", "3003737899", "2518435", "3013596024", "3008496839", "2126666", "3007965489", "1000512168", "3002807167", "3010041511", "3002807439", "3001236549", "3010155661", "1000222374", "3013320573", "3000126629", "2011171", "2183744", "3003263092" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }