{ "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": 2 } }, "results": [ { "cfres_id": "198320", "product_res_number": "Z-1147-2023", "event_date_initiated": "2023-02-07", "event_date_posted": "2023-03-09", "recall_status": "Open, Classified", "res_event_number": "91603", "product_code": "DSP", "k_numbers": [ "K181122" ], "product_description": "Cardiosave Hybrid\n\nModel Nos. 0998-00-0800-31\n0998-00-0800-32\n0998-00-0800-33\n0998-00-0800-34\n0998-00-0800-35\n0998-00-0800-45\n0998-00-0800-52\n0998-00-0800-53\n0998-00-0800-55\n0998-00-0800-65\n\n0998-UC-0800-31*\n0998-UC-0800-33*\n0998-UC-0800-52*\n0998-UC-0800-53*\n0998-00-0800-55*\n\n* -- not distributed in US", "code_info": "Model\t UDI\n0998-00-0800-31\t10607567109053\n0998-00-0800-32\t10607567111117\n0998-00-0800-33\t10607567109008\n0998-00-0800-34\t10607567111940\n0998-00-0800-35\t10607567109107\n0998-00-0800-45\t10607567108421\n0998-00-0800-52\t10607567108438\n0998-00-0800-53\t10607567108391\n0998-00-0800-55\t10607567108414\n0998-00-0800-65\t10607567113432\n0998-UC-0800-31*\tN/A\n0998-UC-0800-33*\tN/A\n0998-UC-0800-52*\tN/A\n0998-UC-0800-53*\tN/A\n0998-00-0800-55*\tN/A\n\nAll serial numbers", "firm_fei_number": "3001418283", "recalling_firm": "Datascope Corp.", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "Ms. Allison Jean Kaplan\n973-709-7779", "reason_for_recall": "An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.", "root_cause_description": "Software design", "action": "On February 7, 2023, the firm notified customers of 4 issues affecting the IABP via an urgent Medical Device Correction letter, which included the present issue.\n\nUsers were instructed to do the following:\n\n1.\tIf you experience an unexpected shutdown of Cardiosave IABP during therapy, or a frozen or black screen, use another IABP to continue therapy. Until an alternative IABP is located you may attempt to restart the IABP. If the IABP remains non-operational, immediately remove from the patient care environment for further product evaluation.\n\n2.\tIf your device remains inoperable, please contact your service representative to identify the cause and take the necessary actions required.\n\nThe firm is developing a software correction to address the issue. Once available, a Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility.\n\nIf you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "product_quantity": "4793 (US); 4407 (OUS)", "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV; and OUS (Foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELRUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE,GERMANY,GHANA,GUATEMALA,HONG KONG,HUNGARY,ICELAND,INDIA,INDONESIA\nIRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO,\nMYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, \nSERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO\nTUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM\nUZBEKISTAN, VIETNAM, YEMEN AND ZAMBIA.", "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" } } ] }