{ "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": 3 } }, "results": [ { "cfres_id": "158120", "product_res_number": "Z-3085-2017", "event_date_initiated": "2017-07-17", "event_date_created": "2017-09-05", "recall_status": "Open, Classified", "res_event_number": "77877", "product_code": "DSP", "k_numbers": [ "K031636" ], "product_description": "CS 100i Intra-Aortic Balloon Pump.\n\nIt supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.", "code_info": "0998-UC-0446HXX; 0998-UC-0479HXX", "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": "Technical Support Department\n888-627-8383", "reason_for_recall": "False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.", "root_cause_description": "Under Investigation by firm", "action": "On July 17, 2017, Maquet/Getinge distributed Urgent Product Recall Medical Device Field Correction and Response Form notices to their U.S. customers via FedEx. Urgent Field Safety Medical Device Field Correction notices were distributed to international customers via email and courier service. Maquet/Getinge advised affected customers to perform risk-benefit assessments with their respective medical team for each patient, when no alternative IABP or alternative therapy is available. Maquet/Getinge provided general information and overall action for the user informing them that:\no\tThe clinicians are instructed not to leave the patient unattended during IABP therapy pursuant to Warnings listed in the Operating Manual. \no\tFor Blood Detection Alarm - Until the service is performed, clinicians are instructed to follow the Blood Detection Alarm Help Screen found in the operating instruction to validate or clear the alarms. Maquet/Getinge recommends that users review the water condensation procedure (CS100/CS100i and CS300 IABP Operating Instructions section 3.4.1) to reduce the potential for condensation accumulation. In the event the IABP fails to successfully cycle and clear the alarm, remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.\no\tFor Fluid Ingression - Until the service is performed, Maquet/Getinge recommends customers review of the CS100/CS100i and CS300 IABP Operating instructions regarding cautions on placement of fluids and hanging of bags of fluid over the IABP.\n\nAll facilities will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service of your CS100/CS100i or CS300 IABP. Customers are advised to complete and return the Medical Device Field Correction Response Form. Please fax the completed form to 1-973-629-1690 or send via email to IABP2017TWO@getinge.com. \n\nIf you a distributor has shipped any affected products to customers, please forward a copy of the docu", "product_quantity": "14,547 units (5,049 domestically & 9,498 units internationally)", "distribution_pattern": "Worldwide Distribution - US Nationwide \nInternational: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,\nAZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE,\nCHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT,\nEL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY,\nGREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY,\nICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,\nJORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA,\nLITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA,\nMAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS,\nNEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE,\nPANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, \nROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN,\nSWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA,\nTURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, \nUNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM &\nYEMEN.", "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" } } ] }