{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66576", "product_res_number": "Z-0567-2008", "event_date_initiated": "2007-11-19", "event_date_posted": "2008-01-31", "recall_status": "Terminated", "event_date_terminated": "2008-05-20", "res_event_number": "45957", "product_code": "DSP", "k_numbers": [ "K063525" ], "product_description": "Datascope CS 100 Intra-Aortic Balloon Pump and Datascope\nCS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430", "code_info": "Serial Numbers: S805991-C2 S805993-C2 SA02504-C4 S806332-G2 S82934-H9 SA03941-F5 S82416-D9 S805969-C2 S806909-B3 S806924-B3 SA03395-A5 SA03407-A5 SI101373-H7 S805404-H1 S81758-K8 S807356-F3 S807013-C3 S806289-F2 S806308-G2 S806282-F2 S806306-G2 S806284-F2 S806292-F2 S806297-G2 SA04871-A6 S806286-F2 S806926-B3 S804246-J0 S805797-A2 S804934-D1  S806155-E2 SI101367-H7 SI100417-H7 S807506-J3 S807042-C3 S81471-I8  SA02801-G4  S8233778-E0 S82518-E9 S803467-B0 SA03469-B5 S806229-F2 S804255-J0 S806193-E2 S806025-D2 S806012-D2 S806019-D2 S806045-D2 S806017-D2 S806024-D2 S805992-C2 S806009-D2 S805581-I1 S82350-C9 S804783-B1 S804793-B1 S804799-B1 S806859-A3 SA01430-A4 SA01152-I3 SA01421-A4 SA01412-A4 S803857-F0 S803775-E0 SA02521-D4 SI01410-E7  S807446-G3 S807470-H3 S806225-F2  and S806259-F2  (These serial numbers do not differentiate between CS100 and CS300, just the board contained within.)", "firm_fei_number": "2221819", "recalling_firm": "Datascope Corp", "address_1": "800 MacArthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2001", "additional_info_contact": "Tim Krauskopf\n201-995-8025", "reason_for_recall": "Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.", "root_cause_description": "Other", "action": "Datascope sent a Product Field Correction notification letters to Hospital Administrators, via certified mail, on November 19, 2007. The letter informed them of a defect in the circuit board. It described the possible malfunction and provided instructions should malfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A Service Representative will be contacting the hospital to arrange for the replacement of the defective board.", "product_quantity": "70 units US", "distribution_pattern": "Worldwide Distribution", "openfda": { "k_number": [ "K963865", "K163542", "K905313", "K965236", "K943919", "K790755", "K993966", "K903893", "K823177", "K810297", "K003598", "K840037", "K200634", "K892799", "K940298", "K840367", "K925248", "K942454", "K895433", "K896430", "K964987", "K920427", "K940231", "K770821", "K831397", "K903736", "K112327", "K830410", "K980780", "K833828", "K801601", "K192238", "K980385", "K020257", "K974247", "K863219", "K935184", "K972113", "K963104", "K060309", "K122628", "K903892", "K760695", "K190117", "K903917", "K915580", "K820882", "K892878", "K983866", "K864568", "K900281", "K063525", "K013326", "K963187", "K954431", "K945230", "K896597", "K190101", "K082746", "K031636", "K010330", "K960166", "K994157", "K896497", "K844220", "K181122", "K864994", "K813023", "K952576", "K922235", "K002949", "K880289", "K790775", "K905056", "K882508", "K926000", "K903930", "K850482", "K973962", "K864567", "K802924", "K903769", "K091449", "K133074", "K781848", "K892798", "K903867", "K040801", "K201112", "K112372", "K860638", "K151254", "K981660", "K860427", "K921638", "K833632", "K904414", "K910997", "K904018", "K811372", "K892222", "K932268", "K863185", "K961358", "K913847", "K790241", "K062582", "K823739", "K936232", "K855102", "K864537", "K162820", "K882274", "K802167", "K820166", "K912629", "K970689", "K924382", "K853062", "K875036", "K232343", "K120868", "K831235", "K892797", "K965209", "K896920", "K962177", "K905663", "K960713", "K821951", "K961509", "K944460", "K041281", "K813355", "K963920", "K831307", "K830411", "K914802", "K971673", "K031569", "K000729", "K893243", "K021462", "K952221", "K902057", "K894942", "K982538", "K940178", "K950687", "K813182", "K823342", "K821065", "K780280", "K250542", "K911000", "K903344", "K070225", "K874816", "K832753", "K980850", "K172305", "K002256" ], "registration_number": [ "3015859709", "2248146", "2011171", "9610816", "3010155661", "3000126629", "3003263092", "3013500228", "3024894463", "3013162291", "3013320573", "2183744", "1319639", "9681477", "2031093", "3008496839", "3013596024", "2518435", "2249723", "9680794", "3002807314", "3010041511", "3009077524", "2032677", "2126666", "1061124", "3007965489", "3010532612" ], "fei_number": [ "3015859709", "1000138054", "2011171", "3010155661", "3001236549", "3000126629", "3003263092", "3013500228", "3024894463", "3001418283", "3003945344", "1000222374", "3002807439", "3013162291", "3013320573", "2183744", "3008496839", "3013596024", "3003737899", "1000512168", "2518435", "3002807314", "3010041511", "3009077524", "2126666", "3007965489", "3002807167", "3010532612" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }