{ "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": "186139", "product_res_number": "Z-1506-2021", "event_date_initiated": "2021-03-22", "event_date_posted": "2021-04-28", "recall_status": "Open, Classified", "res_event_number": "87482", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K163542" ], "product_description": "Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 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 Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432", "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\n973-709-7442", "reason_for_recall": "There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).", "root_cause_description": "Software design", "action": "URGENT MEDICAL DEVICE CORRECTION notification letters dated 3/22/21 were distributed to customers. \n\nPLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL\nCARDIOSAVE HYBRID and CARDIOSAVE RESCUE IABP USERS WITHIN YOUR\nHOSPITAL / FACILITY.\n\nIF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS\nTO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION\nFOR APPROPRIATE ACTION.\n\nCorrective Action:\nDatascope/Getinge is currently developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility.\n\nPlease complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the\ncompleted form to Datascope/Getinge by e-mailing a scanned copy to cardiosaveripple20.act@getinge.com or by faxing the form to 1-800-506-1644.", "product_quantity": "10087 total", "distribution_pattern": "Worldwide distribution - US Nationwide distribution.", "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" } } ] }