{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "198422", "product_res_number": "Z-1276-2023", "event_date_initiated": "2023-02-28", "event_date_posted": "2023-03-22", "recall_status": "Open, Classified", "res_event_number": "91652", "product_code": "DSP", "k_numbers": [ "K112372" ], "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65", "code_info": "Model Number: 0998-00-0800-31, UDI-DI: 10607567109053;\nModel Number: 0998-00-0800-32, UDI-DI: 10607567111117;\nModel Number: 0998-00-0800-33, UDI-DI: 10607567109008;\nModel Number: 0998-00-0800-35, UDI-DI: 10607567109107;\nModel Number: 0998-00-0800-45, UDI-DI: 10607567108421;\nModel Number: 0998-00-0800-52, UDI-DI: 10607567108438;\nModel Number: 0998-00-0800-53, UDI-DI: 10607567108391;\nModel Number: 0998-00-0800-55, UDI-DI: 10607567108414;\nModel Number: 0998-00-0800-65, UDI-DI: 10607567113432;\n\nSerial Numbers: CB355244F2, CB355245F2, CB356759G2, CB356760G2, CB351303D2\nCB355431F2\nCB355432F2\nCB355433F2\nCB355434F2\nCB355435F2\nCB356761G2\nCB356762G2\nCB356763G2\nCB356764G2\nCB356765G2\nCB351313D2\nCB352952E2\nCB352953E2\nCB355240F2\nCB355241F2\nCB355242F2\nCB355243F2\nCB356766G2\nCB356767G2\nCB356768G2\nCB356769G2\nCB356770G2\nCH351787D2\nCH352224D2\nCH352225D2\nCH352228D2\nCH352280E2\nCH352283E2\nCH352284E2\nCH352287E2\nCH352289E2\nCH352290E2\nCH352297E2\nCH352298E2\nCH353439E2\nCH353443E2\nCH353445E2\nCH353448E2\nCH353451E2\nCH353454E2\nCH353795F2\nCH353796F2\nCH353797F2\nCH353798F2\nCH353799F2\nCH353801F2\nCH353802F2\nCH353803F2\nCH353804F2\nCH353805F2\nCH353806F2\nCH353807F2\nCH353808F2\nCH353809F2\nCH353810F2\nCH353811F2\nCH353812F2\nCH353813F2\nCH353814F2\nCH354143F2\nCH354144F2\nCH354145F2\nCH354146F2\nCH354147F2\nCH354148F2\nCH354149F2\nCH354150F2\nCH354151F2\nCH354152F2\nCH354153F2\nCH354154F2\nCH354155F2\nCH354156F2\nCH354157F2\nCH354158F2\nCH354159F2\nCH354160F2\nCH354161F2\nCH354162F2\nCB351043D2\nCB351792D2\nCB352956E2\nCB353456E2\nCB354411F2\nCB354412F2\nCB354413F2\nCB354414F2\nCB354415F2\nCB354416F2\nCB354417F2\nCB354418F2\nCB354419F2\nCB355239F2\nCB356772G2\nCB356773G2\nCB356774G2\nCB356775G2\nCB356776G2\nCA209023D2 CH257564F7 CH352970E2 CH355589F2\nCA211084E2 CH257750F7 CH352973E2 CH355590F2\nCA212105F2 CH260122H7 CH352975E2 CH355591F2\nCA212724F2 CH260980H7 CH352976E2 CH355592F2\nCA213851G2 CH261704H7 CH352979E2 CH355593F2\nCA214935H2 CH263200I7 CH352981E2 CH355594F2\nCA216307I2 CH263202I7 CH352983E2 CH355595F2\nCA217776J2 CH263207I7 CH352986E2 CH355596F2\nCA217786J2 CH263209I7 CH353368E2 CH355597F2\nCA226551D3 CH263211I7 CH353370E2 CH355708G2\nCA226957D3 CH265706J7 CH353371E2 CH355709G2\nCA227974E3 CH266125J7 CH353372E2 CH355710G2\nCA227979E3 CH266143J7 CH353373E2 CH355711G2\nCA229121E3 CH266878K7 CH353374E2 CH355712G2\nCA237955K3 CH269587L7 CH353376E2 CH355713G2\nCA245024D4 CH270087L7 CH353378E2 CH355714G2\nCA246297E4 CH270088L7 CH353381E2 CH355715G2\nCA247925F4 CH271216A8 CH353383E2 CH355716G2\nCA249755G4 CH274609C8 CH353385E2 CH355717G2\nCA251232H4 CH276227D8 CH353386E2 CH355718G2\nCA251252H4 CH276230D8 CH354420F2 CH355719G2\nCA251720I4 CH277366D8 CH354421F2 CH355720G2\nCH203093L4 CH277844E8 CH354422F2 CH355721G2\nCH203613L4 CH279405E8 CH354423F2 CH355722G2\nCH203794L4 CH280574F8 CH354424F2 CH355723G2\nCH203795L4 CH284286H8 CH354425F2 CH355724G2\nCH208131C5 CH284289H8 CH354426F2 CH355725G2\nCH210973E5 CH284293H8 CH354427F2 CH355726G2\nCH210974E5 CH285038H8 CH354428F2 CH355727G2\nCH212821F5 CH286421I8 CH354429F2 CH356090G2\nCH214976G5 CH286990I8 CH354430F2 CH356091G2\nCH215363G5 CH289804J8 CH354431F2 CH356092G2\nCH216809H5 CH289805J8 CH354432F2 CH356093G2\nCH216816H5 CH289806J8 CH354433F2 CH356094G2\nCH220795J5 CH291673K8 CH354434F2 CH356095G2\nCH222872K5 CH293251L8 CH354435F2 CH356096G2\nCH222888K5 CH293258L8 CH354436F2 CH356097G2\nCH222889K5 CH296588B9 CH354437F2 CH356098G2\nCH222891K5 CH299569C9 CH354438F2 CH356099G2\nCH222897K5 CH299573C9 CH354439F2 CH356100G2\nCH222898K5 CH303093E9 CH354724F2 CH356101G2\nCH223512K5 CH307520G9 CH354725F2 CH356102G2\nCH223540K5 CH308230H9 CH354726F2 CH356103G2\nCH232203D6 CH311931I9 CH354727F2 CH356104G2\nCH232213D6 CH312530J9 CH354728F2 CH356105G2\nCH233414E6 CH314067J9 CH354729F2 CH356106G2\nCH233420E6 CH314077J9 CH354730F2 CH356107G2\nCH235254F6 CH314282J9 CH354731F2 CH356108G2\nCH235259F6 CH314284J9 CH354732F2 CH356109G2\nCH236295F6 CH314289J9 CH354733F2 CH356246G2\nCH236307F6 CH315552K9 CH354734F2 CH356247G2\nCH246500L6 CH315555K9 CH354735F2 CH356248G2\nCH247705L6 CH316289L9 CH354736F2 CH356249G2\nCH250188B7 CH330263K0 CH354737F2 CH356250G2\nCH250993B7 CH330725L0 CH354738F2 CH356251G2\nCH251004B7 CH331534L0 CH354739F2 CH356252G2\nCH252916C7 CH335172D1 CH354740F2 CH356253G2\nCH256993E7 CH338672F1 CH354741F2 CH356254G2\nCH257551F7 CH341944I1 CH354742F2 CH356255G2\nCH257558F7 CH345853L1 CH354743F2 CH358824I2\nCH257561F7 CH351793D2 CH355588F2\nCA222643A3\nCB293277L8\nCB351786D2\nCB352696E2\nCB352698E2\nCB352701E2\nCB352702E2\nCB352703E2\nCB352958E2\nCB355439F2\nCB355440F2\nCB355441F2\nCB355442F2\nCB355443F2\nCB352222D2\nCB352223D2\nCB353458E2\nCB353460E2\nCB353462E2\nCB353464E2\nCB353568F2\nCB353569F2\nCB353572F2\nCB353573F2\nCB353574F2\nCB353575F2\nCB353577F2\nCB353578F2\nCB353579F2\nCB353580F2\nCB353581F2\nCB353582F2\nCB356771G2\nCH250188B7 \nCH330725L0 \nCH354741F2 \nCH360749K2\nCH250993B7 \nCH331534L0 \nCH354742F2\nCH251004B7 \nCH335172D1 \nCH354743F2", "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 is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE CORRECTION dated 2/28/23 was sent to customers.\n\nUser Actions to be taken:\nA review of our records indicate that you may have a Cardiosave IABP at your facility with an affected Safety Disk or affected spare Safety Disks or PIM assembly installed recently into Cardiosave IABP.\n1. Please examine your inventory immediately to determine if you have any Cardiosave IABPs with the affected Safety Disks and/or PIM, or any affected Safety Disk and/or PIM assembly spare parts, per attachment 1.\n2. You may continue to use any affected IABPs until replacement parts are installed. Please keep in mind the potential health risks cited above, particularly with prolonged heart rates above 100 beats per minute for three consecutive hours. When transporting patients outside the hospital environment, consider using an unaffected console if available.\n3. Should you have any unused affected spare parts of the Safety Disk or PIM Assembly in your inventory, please remove them from areas of use and contact your local Datascope/Getinge Customer Service department at 888-9GETUSA (888 943-8872) to request a return authorization (RMA) and shipping instruction to return the affected product for credit.\n4. If you installed an affected spare part into one of your IABPs the Safety Disk will need to be replaced.\n5. If you purchased spare parts and they are no longer in your inventory and you are unsure of their location, please contact Getinge Service. Getinge Service will schedule an on-site visit to inspect your IABP/(s) at no cost to your facility.\n6. Should you have any affected Cardiosave IABPs you will be contacted by a Getinge Service Representative to schedule an on-site visit to replace the Safety Disk, free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone", "product_quantity": "391 total IABPs", "distribution_pattern": "Distribution list not yet provided.", "openfda": { "k_number": [ "K911000", "K864994", "K821065", "K892878", "K875036", "K882508", "K190117", "K940298", "K021462", "K920427", "K863185", "K915580", "K802167", "K894942", "K896920", "K963104", "K162820", "K250542", "K912629", "K963187", "K181122", "K903892", "K940231", "K855102", "K833828", "K112372", "K163542", "K974247", "K003598", "K010330", "K831397", "K954431", "K864567", "K905663", "K060309", "K900281", "K823342", "K980850", "K896597", "K192238", "K952576", "K980385", "K874816", "K232343", "K780280", "K896497", "K853062", "K972113", "K964987", "K903867", "K921638", "K973962", "K823739", "K902057", "K000729", "K813023", "K823177", "K910997", "K963920", "K903769", "K082746", "K860638", "K820166", "K904414", "K830411", "K965236", "K896430", "K982538", "K831235", "K880289", "K952221", "K860427", "K903930", "K962177", "K914802", "K172305", "K895433", "K013326", "K040801", "K905056", "K833632", "K002256", "K905313", "K961358", "K926000", "K062582", "K801601", "K770821", "K960166", "K122628", "K813182", "K892222", "K945230", "K963865", "K813355", "K790755", "K031636", "K943919", "K994157", "K811372", "K944460", "K190101", "K965209", "K935184", "K864537", "K112327", "K832753", "K790775", "K892798", "K002949", "K063525", "K925248", "K892799", "K041281", "K831307", "K903736", "K903893", "K882274", "K201112", "K840037", "K913847", "K781848", "K020257", "K971673", "K810297", "K151254", "K200634", "K980780", "K893243", "K970689", "K922235", "K960713", "K821951", "K091449", "K903344", "K932268", "K936232", "K133074", "K961509", "K942454", "K950687", "K790241", "K760695", "K830410", "K940178", "K802924", "K903917", "K924382", "K993966", "K864568", "K031569", "K840367", "K892797", "K981660", "K070225", "K863219", "K983866", "K850482", "K844220", "K904018", "K820882", "K120868" ], "registration_number": [ "9680794", "3010155661", "2126666", "3002807314", "3015859709", "3000126629", "2032677", "3013320573", "2183744", "3013500228", "3003263092", "1319639", "2031093", "2249723", "9610816", "1061124", "3013162291", "2248146", "3010532612", "9681477", "3024894463", "2518435", "2011171", "3007965489", "3009077524", "3013596024", "3010041511", "3008496839" ], "fei_number": [ "3002807439", "3010155661", "2126666", "1000512168", "3002807314", "3001236549", "3015859709", "3000126629", "3013320573", "2183744", "3013500228", "3003263092", "3013162291", "3010532612", "3024894463", "3003945344", "2518435", "2011171", "1000138054", "3007965489", "3009077524", "3013596024", "3001418283", "3010041511", "1000222374", "3008496839", "3002807167", "3003737899" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }