{ "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": "167361", "product_res_number": "Z-0099-2019", "event_date_initiated": "2018-09-20", "event_date_posted": "2018-10-27", "recall_status": "Open, Classified", "res_event_number": "81055", "product_code": "DSP", "k_numbers": [ "K181122" ], "product_description": "Cardiosave Hybrid IABP, Part Number 0998-00-0800-53", "code_info": "UDI - 10607567108391 All Serial Numbers", "firm_fei_number": "3001418283", "recalling_firm": "Maquet Datascope Corp - Cardiac Assist Division", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "973-244-6138", "reason_for_recall": "There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.", "root_cause_description": "Device Design", "action": "On September 20, 2018, Maquet/Getinge issued a press release. On September 24, 2018 and on September 28, 2018, Maquet/Getinge issued URGENT MEDICAL DEVICE CORRECTION notices along with an Instructions for Use Addendum to customers. On October 23, 2018 a modified version of the Urgent Medical Device Correction Letter and response form was sent to 23 new U.S. consignees who received Cardiosave IABP devices after the ship-hold was released. The post ship-hold devices contain the IFU addendum.\nThis modified version of the letter notifies customers of the altitude issue and the required software update. Maquet/Getinge is currently developing a software correction to address this issue. \n\nCustomers are encouraged to use the following items as specified according to altitude levels:\n\nSensation 34cc / 40cc (Balloon Name and Size) \nSensation Plus 40cc / 50cc (Balloon Name and Size)\t\nOperating Altitude:\n-1250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1060 hPa to 901 hPa)\n\nMega 50cc\t (Balloon Name & Size)\nOperating Altitude: \n-1250 feet to 5000 feet (795 mmHg to 632 mmHg) (1060 hPa to 843 hPa)\n\nMega 30cc / 40cc (Balloon Name & Size)\nLinear 25cc / 34cc / 40cc (Balloon Name & Size)\t\nOperating Altitude:\n-1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa)\n\nFor technical questions, please contact Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST", "distribution_pattern": "US Nationwide; Internationally to 77 countries", "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" } } ] }