{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189393", "product_res_number": "Z-0091-2022", "event_date_initiated": "2021-09-21", "event_date_posted": "2021-10-20", "recall_status": "Open, Classified", "res_event_number": "88719", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K163542", "K181122" ], "product_description": "Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers.\n\n1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55.\n\n2. Cardiosave Rescue. Model Number: 0998-00-0800-83.", "code_info": "Battery Pack Serial Numbers: 192224349IP, 191908720IP, 202369811IP, 202791944IP, 191848115IP, 192099841IP, 192103741IP, 192104141IP, 171218521PE, 181642339PE, 202321308IP, 191912520IP, 191874716IP, 191922620IP, 181642639PE, 192185446IP, 171277935PE, 192190247IP, 202400219IP, 202323808IP, 191910720IP, 181661142PE, 192245250IP, 202599332IP, 181645841PE, 181526530PE, 202403719IP, 181705244PE, 192104541IP, 191787312IP, 181646041PE, 191955422IP, 202389919IP, 191822513IP, 191853415IP, 192004724IP, 192196447IP, 192155645IP, 202330609IP, 171325749PE, 192018828IP, 191778911IP, 192187947IP, 192196247IP, 181609237PE, 192098341IP, 191972823IP, 191860615IP, 202719740IP, 202334109IP, 202651035IP, 191852615IP, 192173146IP, 202386519IP, 202398619IP, 202416720IP, 202599432IP, 191956322IP, 192205847IP, 192220349IP, 192081138IP, 202617233IP, 181659242PE, 202266705IP, 171255732PE, 192179046IP, 192179246IP, 202280605IP, 181673143PE, 192083838IP, 192106442IP, 192216649IP, 191956122IP, 181721730IP, 191943120IP, 191971023IP, 181405120PE, 181474326PE, 181440222PE, 192225649IP, 191969623IP, 192220749IP, 181706344PE, 181694644PE, 191968223IP, 202593632IP, 191863015IP, 171264133PE, 191872616IP, 181487828PE, 171337749PE, 181477426PE, 181748032IP, 191790412IP, 191902319IP, 192195547IP, 192200947IP, 191968723IP, 202552831IP, 191806513IP, 202401419IP, 191904319IP, 181492328PE, 202388319IP, 202482724IP, 192241550IP, 171339849PE, 191831214IP, 192084038IP, 181694244PE, 192210249IP, 202725540IP, 171345550PE, 171348550PE, 191915920IP, 202371511IP, 202723440IP, 202367411IP, 202279305IP, 181513630PE, 181703744PE, 202389819IP, 192175646IP, 192107842IP, 202394719IP, 202401619IP, 192204947IP, 202654636IP, 192196647IP, 192200647IP, 202782744IP.\n\n1. Cardiosave Hybrid. Model Number (UDI Number): 0998-00-0800-31 (10607567109053), 0998-00-0800-32 (10607567111117), 0998-00-0800-33 (10607567109008), 0998-00-0800-35 (10607567109107), 0998-00-0800-36 (10607567114187), 0998-00-0800-45 (10607567108421), 0998-00-0800-52 (10607567108438), 0998-00-0800-53 (10607567108391), 0998-00-0800-55 (10607567108414), 0998-00-0800-65 (10607567113432), 0998-UC-0800-31 (10607567109053), 0998-UC-0800-33 (10607567109008), 0998-UC-0800-52 (10607567108438), 0998-UC-0800-53 (10607567108391), 0998-UC-0800-55 (10607567108414).\n\n2. Cardiosave Rescue. Model Number: 0998-00-0800-83 (10607567108407).", "firm_fei_number": "3001418283", "recalling_firm": "Datascope Corp.", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "Rachana Patel\n973-709-7412", "reason_for_recall": "A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.", "root_cause_description": "Nonconforming Material/Component", "action": "On September 21, 2021, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were alerted that affected battery packs may experience unexpected short battery runtime.\n\nActions to be Taken by Customer:\n\n- Examine your inventory to determine if you have any of the affected product\n- Replace any affected battery with an unaffected battery, and remove affected product from areas of use\n- Dispose of affected batteries properly in accordance with local statutes and the labeling on the battery pack\n- Customers with affected product are eligible for credit or replacement at no cost\n- Forward information to all current and potential Cardiosave Hybrid and Cardiosave Rescue IABP users within your hospital/facility\n- Distributors should forward notification to affected customers\n- Respond to firm's notification by completing the included response form\n\nOn 11/04/2025, Datascope Getinge sent a customer update letter (i.e. Urgent Medical Device Correction) to communicate the IFU Addendum to consignees on 11/04/2025. The addendum communicates changes regarding the battery run time specification. The IFU Addendum updates the battery runtime specification to match those published in the Service Manual in June 2023. The notification also includes information regarding other issues related to the recall and being communicated to users of the Cardiosave pumps.", "product_quantity": "131 batteries, 11,517 pumps", "distribution_pattern": "Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates, Philippines, and Russia", "openfda": { "k_number": [ "K063525", "K904414", "K892798", "K965209", "K003598", "K112327", "K900281", "K250542", "K790775", "K896430", "K201112", "K943919", "K122628", "K002949", "K902057", "K932268", "K120868", "K914802", "K813023", "K031569", "K830411", "K913847", "K896597", "K010330", "K760695", "K850482", "K963104", "K832753", "K882274", "K112372", "K982538", "K060309", "K031636", "K831307", "K831397", "K926000", "K905313", "K960166", "K770821", "K925248", "K041281", "K820882", "K190117", "K942454", "K994157", "K963865", "K831235", "K813355", "K952221", "K021462", "K070225", "K875036", "K980850", "K922235", "K973962", "K813182", "K903930", "K905056", "K780280", "K892797", "K912629", "K962177", "K863219", "K903736", "K963187", "K915580", "K921638", "K880289", "K971673", "K232343", "K874816", "K983866", "K960713", "K823342", "K940298", "K020257", "K954431", "K892222", "K903892", "K190101", "K013326", "K864537", "K936232", "K882508", "K163542", "K151254", "K894942", "K940178", "K911000", "K162820", "K974247", "K981660", "K896920", "K864568", "K000729", "K082746", "K781848", "K961358", "K833632", "K823177", "K920427", "K830410", "K904018", "K853062", "K905663", "K860638", "K821065", "K040801", "K924382", "K892799", "K200634", "K903867", "K964987", "K965236", "K972113", "K181122", "K002256", "K895433", "K903769", "K820166", "K790241", "K980385", "K961509", "K810297", "K903917", "K844220", "K821951", "K940231", "K980780", "K944460", "K903893", "K903344", "K802924", "K896497", "K833828", "K864994", "K952576", "K802167", "K790755", "K840037", "K963920", "K893243", "K855102", "K935184", "K892878", "K172305", "K950687", "K801601", "K062582", "K840367", "K091449", "K860427", "K910997", "K945230", "K970689", "K133074", "K192238", "K993966", "K811372", "K863185", "K823739", "K864567" ], "registration_number": [ "9681477", "9680794", "2249723", "3013500228", "1319639", "3009077524", "2032677", "3002807314", "3015859709", "2183744", "3013162291", "9610816", "1061124", "2518435", "3003263092", "3008496839", "3000126629", "3013320573", "3024894463", "2126666", "3007965489", "2011171", "3010155661", "2248146", "3010041511", "3013596024", "2031093", "3010532612" ], "fei_number": [ "3001418283", "3013500228", "3002807167", "3009077524", "3002807314", "3015859709", "2183744", "3001236549", "3013162291", "2518435", "3003263092", "1000222374", "3008496839", "3000126629", "3013320573", "1000512168", "3024894463", "1000138054", "2126666", "3007965489", "3002807439", "2011171", "3010155661", "3003945344", "3010041511", "3013596024", "3003737899", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }