{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "195411", "product_res_number": "Z-1685-2022", "event_date_initiated": "2022-08-05", "event_date_posted": "2022-09-08", "recall_status": "Open, Classified", "res_event_number": "90684", "product_code": "DSP", "k_numbers": [ "K133074" ], "product_description": "MEGA 8Fr 50cc Intra-Aortic Balloon Catheter", "code_info": "Code information reads \"UDI-DI, Lot No., Finished Goods Part No.\": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.", "firm_fei_number": "1000222374", "recalling_firm": "Datascope Corporation", "address_1": "15 Law Dr", "city": "Fairfield", "state": "NJ", "postal_code": "07004-3206", "additional_info_contact": "Datascope Corp./Getinge Customer Support\n1-888-943-8872 Ext. 2", "reason_for_recall": "Certain lots containing undersized dilator.", "root_cause_description": "Vendor change control", "action": "The firm distributed an Urgent Medical Device Removal notification, by mail, dated August 5, 2022. The notification informs customers that certain lots of 8Fr. 50cc IAB catheter and insertion kits are being recalled due to an undersized vessel dilator. During a sheathless insertion, the undersized inner diameter may result in the inability to insert the guidewire through the inner lumen of the dilator and the undersized outer diameter may reduce dilation of the vessel. If used in a procedure, recalled product could result in a procedural delay, gas emoli, and vessel injury. \n\nCustomers are asked to examine their inventory to determine if they have nay recalled product and to quarantine any affected units. Customers with recalled product are to contact Datascope Corp./Getinge Customer Service at 888-9GETUSA (888-943-8872, option 2) between the hours of 8 AM and 6 PM to request a return authorization number to receive full credit. \n\nDistributors who have shipped any product are to forward the notification to customers. The recall notification is to be forwarded to all users at hospitals/facilities. \n\nCustomers are asked to complete and return the recall response form by email to Dilator8Fr2022@getinge.com or by fax to 877-647-1921.", "product_quantity": "10,427 units", "distribution_pattern": "Awaiting domestic distribution.\nForeign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong,\nIceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland,\nPortugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden,\nSwitzerland, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K894942", "K864994", "K813355", "K940178", "K963104", "K915580", "K002256", "K971673", "K935184", "K122628", "K925248", "K190101", "K813182", "K922235", "K892799", "K952576", "K980780", "K790241", "K882274", "K921638", "K811372", "K982538", "K003598", "K133074", "K192238", "K820882", "K000729", "K082746", "K853062", "K892878", "K860427", "K833632", "K770821", "K031636", "K972113", "K823739", "K903893", "K944460", "K911000", "K893243", "K950687", "K875036", "K830411", "K250542", "K932268", "K974247", "K952221", "K942454", "K914802", "K963865", "K040801", "K863185", "K781848", "K904414", "K924382", "K091449", "K790755", "K010330", "K832753", "K905313", "K831307", "K945230", "K232343", "K790775", "K892798", "K961509", "K190117", "K002949", "K983866", "K905663", "K802167", "K892222", "K981660", "K960713", "K172305", "K820166", "K802924", "K994157", "K831235", "K860638", "K844220", "K151254", "K961358", "K903867", "K850482", "K963187", "K162820", "K903736", "K965236", "K830410", "K910997", "K980385", "K903344", "K904018", "K905056", "K163542", "K912629", "K940298", "K200634", "K980850", "K864568", "K896430", "K896920", "K926000", "K823177", "K903917", "K801601", "K063525", "K892797", "K903892", "K874816", "K943919", "K020257", "K120868", "K823342", "K954431", "K112372", "K962177", "K062582", "K021462", "K882508", "K896497", "K993966", "K013326", "K831397", "K900281", "K813023", "K902057", "K060309", "K895433", "K112327", "K864537", "K864567", "K960166", "K181122", "K913847", "K855102", "K903769", "K070225", "K833828", "K041281", "K903930", "K970689", "K810297", "K821065", "K201112", "K780280", "K840037", "K840367", "K920427", "K863219", "K964987", "K973962", "K965209", "K896597", "K963920", "K821951", "K940231", "K031569", "K880289", "K760695", "K936232" ], "registration_number": [ "9681477", "2518435", "3007965489", "3010532612", "1319639", "2011171", "2249723", "3013500228", "3013596024", "3002807314", "2248146", "3010041511", "3013320573", "2183744", "1061124", "3009077524", "3024894463", "2031093", "2032677", "3000126629", "3010155661", "9610816", "3008496839", "9680794", "3013162291", "3015859709", "2126666", "3003263092" ], "fei_number": [ "2518435", "3007965489", "3010532612", "1000138054", "2011171", "1000222374", "3013500228", "3013596024", "3002807314", "3003945344", "3001236549", "3010041511", "3013320573", "2183744", "3009077524", "3024894463", "1000512168", "3001418283", "3000126629", "3010155661", "3002807167", "3008496839", "3013162291", "3002807439", "3003737899", "3015859709", "2126666", "3003263092" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }