{ "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": "217303", "product_res_number": "Z-0916-2026", "event_date_initiated": "2025-11-04", "event_date_posted": "2025-12-11", "recall_status": "Open, Classified", "res_event_number": "97946", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K181122" ], "product_description": "Cardiosave Hybrid. Intra-Aortic Balloon Pump system.", "code_info": "Model No. (UDI): 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-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.", "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 revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.", "root_cause_description": "Component design/selection", "action": "An URGENT MEDICAL DEVICE CORRECTION NOTICE, dated October 2025, was sent via FEDEX to consignees. The notification notifies consignees of four addendum updates: 1) NVRAM Preventive Maintenance (New FSCA - reflected in this recall entry), 2) Vibration and Shock Table Specifications (New FSCA), 3) Helium O-Ring Preventive Maintenance (FSCA 2249723-01/24/2023-004-C), and 4) Battery Runtime Specifications (FSCA 2249723-09/10/2021-001-R). The notification instructs consignees regarding the NVRAM Preventive Maintenance to review the provided IFU addendum, update local preventive maintenance procedures as such, and ensure all NVRAM batteries are within their life expectancy. If a NVRAM is greater than 8 years old, until it can be replaced, it is advised a back-up Cardiosave IABP be available to provide therapy. Consignees with any questions can contact Datascope/Getinge Customer Support at 1-88-943-8872 (options 4, 2, 1) Monday through Friday, from 8:00 AM EST and 6:00 PM EST.", "product_quantity": "11,470 units", "distribution_pattern": "Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, 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, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.", "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" } } ] }