{ "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": 1 } }, "results": [ { "cfres_id": "164199", "product_res_number": "Z-1928-2018", "event_date_initiated": "2018-05-03", "event_date_created": "2018-05-31", "recall_status": "Open, Classified", "res_event_number": "80003", "product_code": "DSP", "k_numbers": [ "K112372", "K151254" ], "product_description": "CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179", "code_info": "All Serial Numbers distributed from 03/06/2012 to 04/26/2018", "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": "973-244-6138", "reason_for_recall": "Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.", "root_cause_description": "Device Design", "action": "Notification of the field correction was posted to the firm's website on 5/3/18 at https://www.maquet.com/globalassets/downloads/product-articles/cardiosave/ml_0730_us_rev_a_cardiosave_fluid_ingress_recall_customer_letter_us_4may2018.pdf. \n\nMailed notification letters will be issued to customers as well.\n\nThe instructions included in the notification includes the following:\n\nPatients receiving IABP therapy are in critical condition. Failure to start or sudden interruption of therapy could result in unsafe, hemodynamic instability. Until the protective top cover is installed, please adhere to the following instructions when using Cardiosave intra-aortic balloon pump:\n1) Pursuant to the Caution section of our Cardiosave IABP Operating/User Instructions, Never place fluids on top of this unit. Make sure that the saline container and tubing do not hang directly over the IABP. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists\n\nIn the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. The Intra-Aortic Balloon (IAB) Catheter Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate, repeat every 5 minutes until either an alternate IABP is available or alternatively, the intra-aortic balloon catheter should be removed from the patient. Please refer to the intra-aortic balloon catheter instructions for use, Manually Inflating and Deflating a Catheter. The patient should be treated according to your facilitys treatment protocols and caregivers clinical judgment to ensure hemodynamic stability.\n\nAffected customers will be contacted by a Maquet/Getinge representative to schedule on-site service of your Cardiosave IABP by a Maquet/ Getinge Sales or Service Re", "product_quantity": "4300", "distribution_pattern": "The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam.\n\nThe devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.", "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" } } ] }