{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210128", "product_res_number": "Z-0311-2025", "event_date_initiated": "2024-09-17", "event_date_posted": "2024-11-05", "recall_status": "Open, Classified", "res_event_number": "95396", "product_code": "DSP", "k_numbers": [ "K041281", "K112327", "K133074" ], "product_description": "MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-\n0295-01", "code_info": "UDI-DI: 10607567107974;\nLot Number: 3000344298", "firm_fei_number": "1000222374", "recalling_firm": "Datascope Corp.", "address_1": "15 Law Dr Unit 1 15 Law Dr", "address_2": "Unit 1", "city": "Fairfield", "state": "NJ", "postal_code": "07004-3206", "additional_info_contact": "Marc De Carlo\n973-709-7725", "reason_for_recall": "There is discrepant labeling on the inner and outer packaging of the device.", "root_cause_description": "Error in labeling", "action": "An URGENT MEDICAL DEVICE REMOVAL notification letter was sent to customers beginning 9/23/24. \n\nActions to be taken by the user:\nOur records indicate that you have received one or more of the affected MEGA 7.5Fr 40cc\nIAB devices. Please examine your inventory immediately to determine if you have any\nimpacted product.\n\nSee pictures of the outer cartons for the potentially impacted product below. Please verify all labels, IFU, and IAB against the artwork on the outer carton.\n\nIf the product, IFU, and labels all match the information for the MEGA 7.5Fr 40cc outer\ncarton (circled green in the second picture below), the device can be used as indicated in\nthe IFU and does not need to be returned.\n\nIf the outer carton states that Lot 3000344298 is a 50cc size (circled red in the first picture below), then this is incorrect and you should return the affected device by contacting Getinge QRC on QRC.UKI@getinge.com.\n\nPlease forward this information to all current and potential Datascope/Getinge IAB users\nwithin your hospital/facility.\n\nIf you are a distributor who has shipped any affected products to customers, please forward this letter to their attention for appropriate action.\n\nWhether or not you have any impacted product, complete and sign the attached Response Form (Page 5) to acknowledge that you have received and understand this notification.\n\nReturn the completed form to Datascope/Getinge by e-mailing a scanned copy or by faxing the form to your local Datascope/Getinge Representative or office.\n\nActions to be taken by Getinge:\nDatascope/Getinge is initiating this Urgent Medical Device Removal to notify users of this IAB labeling issue.\n\nThis voluntary removal only affects the products identified above that are manufactured for lot number 3000344298; no other products are affected.\n\nEmail: QRC.UKI@getinge.com", "product_quantity": "160 units", "distribution_pattern": "International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.", "openfda": { "k_number": [ "K002949", "K063525", "K112372", "K936232", "K840037", "K830410", "K972113", "K781848", "K994157", "K151254", "K120868", "K813023", "K940178", "K875036", "K820882", "K013326", "K910997", "K821951", "K850482", "K853062", "K894942", "K840367", "K896597", "K031636", "K060309", "K903736", "K945230", "K770821", "K163542", "K882508", "K904018", "K000729", "K932268", "K950687", "K904414", "K801601", "K192238", "K905056", "K832753", "K911000", "K981660", "K920427", "K844220", "K864568", "K896497", "K903867", "K963920", "K903344", "K790241", "K780280", "K201112", "K823177", "K940298", "K830411", "K833828", "K831235", "K921638", "K892799", "K864567", "K912629", "K892222", "K002256", "K973962", "K232343", "K831307", "K980780", "K935184", "K813355", "K963104", "K821065", "K041281", "K200634", "K903892", "K882274", "K926000", "K802924", "K952576", "K971673", "K895433", "K070225", "K863219", "K863185", "K020257", "K942454", "K960166", "K960713", "K813182", "K021462", "K003598", "K914802", "K790755", "K190101", "K820166", "K905663", "K823342", "K924382", "K831397", "K983866", "K790775", "K925248", "K880289", "K896920", "K864537", "K962177", "K122628", "K980850", "K172305", "K974247", "K760695", "K944460", "K864994", "K943919", "K903893", "K903917", "K874816", "K823739", "K902057", "K860427", "K091449", "K970689", "K250542", "K892798", "K893243", "K922235", "K162820", "K181122", "K952221", "K915580", "K811372", "K903930", "K964987", "K993966", "K802167", "K190117", "K965209", "K982538", "K963187", "K900281", "K112327", "K965236", "K905313", "K892797", "K031569", "K980385", "K860638", "K896430", "K963865", "K892878", "K082746", "K940231", "K062582", "K954431", "K133074", "K810297", "K903769", "K040801", "K913847", "K833632", "K010330", "K961358", "K855102", "K961509" ], "registration_number": [ "3002807314", "9610816", "2032677", "3024894463", "3010155661", "3009077524", "2126666", "3015859709", "3013162291", "2011171", "2248146", "1061124", "3007965489", "9681477", "2031093", "3003263092", "3010041511", "3008496839", "3013320573", "3013596024", "1319639", "2183744", "2249723", "9680794", "3013500228", "2518435", "3000126629", "3010532612" ], "fei_number": [ "3002807314", "3024894463", "3010155661", "1000138054", "1000222374", "3009077524", "2126666", "3015859709", "3013162291", "2011171", "3002807439", "3007965489", "3001418283", "3001236549", "3003263092", "3010041511", "3008496839", "1000512168", "3013320573", "3013596024", "2183744", "3003737899", "3003945344", "3013500228", "2518435", "3000126629", "3002807167", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }