{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "173075", "product_res_number": "Z-1939-2019", "event_date_initiated": "2019-06-17", "event_date_posted": "2019-07-16", "recall_status": "Open, Classified", "res_event_number": "82897", "product_code": "DSP", "k_numbers": [ "K112372", "K151254", "K163542", "K181122" ], "product_description": "Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53\nFor cardiovascular use.", "code_info": "All serial numbers affected", "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. Marylou Insinga\n973-709-7442", "reason_for_recall": "Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.", "root_cause_description": "Use error", "action": "On June 17, 2019, the firm notified its customers of the product issue via Urgent Medical Device Correction letters.\n\nCustomers are to take the following immediate interim actions:\n\n\" Ensure the IABP is plugged into an AC power outlet whenever possible during patient use to prevent the\nbattery from depleting.\n\" Ensure the IABP is plugged into an AC power outlet when the system is not in use. The batteries should be\nkept at a full charge even when the IABP is not in use.\n\" When transporting patients within or between facilities, please refer to the IABP Operating Instructions\nManual for recommendations on portable/battery operation. For example:\n\" Prior to portable operation, the battery should be fully charged\n\" For Cardiosave Rescue and Cardiosave Hybrid only:\n\" Additional charged batteries should be on hand during transport\n\" Ensure the batteries are properly seated in the battery compartment/charger and the IABP\nConsole is completely seated/secured into the IABP Cart\n\" For Cardiosave Hybrid, you can verify if the Console is completely seated in the IABP\ncart by the indicator on the display.\n\nCheck battery run time and replace batteries as required, as recommended in each IABPs Operating\nInstructions Manual. A reduction in run time can occur over a battery's life for reasons such as age, storage\ntemperature and discharge depth. Batteries should be replaced:\n\" After reaching the maximum number of charge-discharge cycles\n\" When the battery provides less than the minimum specified run time\n\" If the battery is broken, cracked, leaking or damaged\n\" When the labeled lifetime of the battery is reached\nNOTE: Batteries for the Cardiosave Hybrid and Cardiosave Rescue IABPs sold before June 2015 should\nbe replaced immediately as the labeled lifetime for these batteries is 4 years. Replacement batteries can\nbe ordered through your sales or service representative. To determine the date of manufacture for all\nCardiosave batteries, refer to attached d", "product_quantity": "6,197", "distribution_pattern": "Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY , RUSSIA , BELGIUM , JAPAN , SAUDI ARABIA , BOLIVIA , JORDAN , SERBIA , BOSNIA AND HERZEGOVINA , KAZAKHSTAN , SINGAPORE , BRAZIL , KENYA , SLOVAKIA , BRUNEI , KOSOVO , SLOVENIA , BULGARIA , KUWAIT , SOUTH AFRICA , CAMBODIA , LATVIA , SOUTH KOREA , CANADA , LEBANON , SPAIN , CHILE , LIBYA , SRI LANKA , CHINA , LITHUANIA , SWEDEN , COLOMBIA , LUXEMBOURG , SWITZERLAND , COSTA RICA , MACAU , SYRIA , CROATIA , MACEDONIA , TAIWAN , CYPRUS , MALAYSIA , TANZANIA , CZECH REPUBLIC , MALDIVES , THAILAND , DENMARK , MALTA , TRINIDAD , DOMINICAN REP , MARTINIQUE , TUNISIA , ECUADOR , MAURITIUS , TURKEY , EGYPT , MEXICO , TURKMENISTAN , EL SALVADOR , MOROCCO , UGANDA , ESTONIA , MYANMAR , UKRAINE , FINLAND , NAMIBIA , UNITED ARAB EMIRATES , FRANCE , NEPAL , UNITED KINGDOM , GEORGIA , NETHERLANDS , URUGUAY , GERMANY , NEW ZEALAND , UZBEKISTAN , GHANA , NIGERIA , VENEZUELA , GREECE , NORTH KOREA , VIETNAM , GUATEMALA , NORWAY , YEMEN , GUYANA , OMAN , ZAMBIA , HONDURAS , PAKISTAN , HONG KONG , and PALESTINE.", "openfda": { "k_number": [ "K924382", "K903344", "K936232", "K902057", "K963187", "K892797", "K960713", "K961509", "K980385", "K040801", "K760695", "K963920", "K905056", "K950687", "K840037", "K831397", "K192238", "K823177", "K863185", "K082746", "K940178", "K000729", "K913847", "K982538", "K940298", "K810297", "K830411", "K882508", "K903892", "K965236", "K940231", "K904018", "K850482", "K875036", "K091449", "K163542", "K120868", "K943919", "K893243", "K993966", "K780280", "K922235", "K920427", "K903893", "K892798", "K912629", "K965209", "K002949", "K864537", "K813355", "K041281", "K903930", "K190117", "K813023", "K790755", "K980780", "K831235", "K151254", "K060309", "K790775", "K896430", "K921638", "K781848", "K900281", "K915580", "K802924", "K896920", "K994157", "K860638", "K911000", "K914802", "K892222", "K892878", "K801601", "K903867", "K823342", "K880289", "K945230", "K973962", "K981660", "K972113", "K830410", "K820882", "K823739", "K905313", "K903917", "K964987", "K021462", "K971673", "K860427", "K010330", "K853062", "K961358", "K954431", "K802167", "K895433", "K003598", "K960166", "K070225", "K122628", "K903736", "K831307", "K894942", "K905663", "K963865", "K944460", "K926000", "K980850", "K833632", "K813182", "K904414", "K833828", "K031636", "K201112", "K974247", "K864568", "K821065", "K190101", "K963104", "K181122", "K952221", "K970689", "K112327", "K983866", "K062582", "K892799", "K863219", "K770821", "K935184", "K232343", "K031569", "K250542", "K002256", "K133074", "K932268", "K112372", "K896497", "K882274", "K952576", "K925248", "K910997", "K874816", "K864567", "K864994", "K840367", "K172305", "K844220", "K896597", "K013326", "K162820", "K200634", "K020257", "K832753", "K962177", "K063525", "K811372", "K820166", "K942454", "K855102", "K821951", "K903769", "K790241" ], "registration_number": [ "9681477", "3010532612", "2031093", "3013500228", "9610816", "1061124", "9680794", "3008496839", "3010155661", "2518435", "3000126629", "3013162291", "1319639", "2183744", "2126666", "3024894463", "3002807314", "2032677", "3009077524", "2249723", "2248146", "3003263092", "3010041511", "3013320573", "3013596024", "3007965489", "3015859709", "2011171" ], "fei_number": [ "3010532612", "3013500228", "3008496839", "3010155661", "2518435", "3000126629", "3013162291", "3003945344", "3001418283", "2183744", "3002807167", "2126666", "3024894463", "3002807314", "1000138054", "3009077524", "3001236549", "3003737899", "3002807439", "3003263092", "1000222374", "3010041511", "3013320573", "1000512168", "3013596024", "3007965489", "3015859709", "2011171" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }