{ "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": "185451", "product_res_number": "Z-1115-2021", "event_date_initiated": "2021-01-11", "event_date_created": "2021-02-12", "recall_status": "Open, Classified", "res_event_number": "87157", "product_code": "JXG", "k_numbers": [ "K042465", "K862907", "K902783", "K951258" ], "product_description": "Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:\n\n24048 - VALVE 24048 DELTA RGL PL 0.5,\n24053 - CHAMBER 24053 DELTA,\n24147 - VALVE 24147 DELTA SML PL0.5,\n25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120,\n25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120,\n25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0,\n25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0,\n25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5,\n25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0,\n25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5,\n27219-1 - VALVE 27219-1 NEONATE DELTA,\n27219-2 - VALVE 27219-2 NEONATE DELTA,\n27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP,\n27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0,\n27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0,\n27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5,\n42812 - VALVE 42812 DELTA SMALL LEVEL I,\n42813 - VALVE 42813 DELTA SMALL LEVEL 1.5,\n42814 - VALVE 42814 DELTA SMALL LEVEL II,\n42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP,\n42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,\n42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP,\n46812 - ASSY 46812 DELTA SHUNT SMALL PL 1,\n46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5,\n46822 - ASSY 46822 DELTA SHUNT REG P/L 1,\n46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5,\n46824 - ASSY 46824 DELTA SHUNT REG P/L 2,\n46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1,\n46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5,\n46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2,\n92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0,\n92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,", "code_info": "Lot numbers for the affected CFNs: 0218796596, 0220173993, 0220631950, 0218806959, 0219354642, 0220201977, 0219404900, 0219404902, 0219501288, 0219501289, 0219869817, 0219278742, 0219278743, 0219278744, 0219698794, 0219809171, 0219948890, 0220112694, 0220180486, 0220217387, 0220262088, 0220397742, 0220397744, 0219272923, 0220279501, 0219278741, 0219927059, 0220149614, 0220393237, 0219281777, 0219948893, 0220166870, 0220236215, 0220720015, 0220285334, 0220285335, 0220285336, 0217135294, 0218720240, 0218720241, 0218992842, 0219621242, 0220251046, 0217135293, 0218720605, 0218721466, 0218721467, 0218721468, 0218992826, 0218992827, 0219154178, 0219289039, 0219289040, 0219312362, 0219761091, 0217135298, 0218720604, 0219284249, 0219284250, 0219761089, 0217150648, 0217244574, 0217244584, 0218721469, 0218721470, 0218986445, 0217135290, 0217286224, 0217344860, 0217344861, 0218720187, 0218753744, 0218753745, 0219312363, 0219800605, 0219802486, 0217135295, 0217135302, 0219423220, 0219761099, 0219279163, 0219278857, 0219278858, 0220352837, 0220398089, 0219279162, 0220400352, 0220602457, 0219279147, 0220352830, 0220088041, 0220602458, 0220285342, 0219894798, 0220398845, 0220285343, 0219067896, 0219067897", "firm_fei_number": "3015531529", "recalling_firm": "Medtronic Neurosurgery", "address_1": "5290 California Ave", "city": "Irvine", "state": "CA", "postal_code": "92617-3073", "reason_for_recall": "Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus", "root_cause_description": "Process control", "action": "On January 11, 2011, the firm issued an \"URGENT: Medical Device Correction\" notification to all affected consignees. In addition to informing consignees about the correction, the firm ask consignees to take the following actions;\n\n1. Be aware that radiopaque marker visualization with impacted devices under radiographic imaging may be\ninsufficient to determine the pressure level and/or flow direction. In these situations, alternative methods\nfor this determination should be considered, if deemed necessary per clinical discretion.\n2. Share this information within your organization to healthcare professionals who monitor patients\nimplanted with these devices.\n3.If desired, radiographic imaging of packaged devices may be conducted pre-operatively to determine\nmarker radiopacity. However, marker visibility of packaged devices under radiographic imaging may not be\nrepresentative of marker visibility post-implant.\n4. Complete and return the enclosed confirmation form to acknowledge receipt of this notification.\nAdditional Information:\n\nMedtronic will honor the return of these products for full credit. If you require a return goods authorization, you\ncan visit http://connect.medtronic.com to initiate your return that is less than 90 days old. For returns over 90\ndays old, please contact Customer Care directly at 1-800-874-5797. Please ensure that you reference FCA 2020-\n12-08-CSF along with the affected batch number(s), original purchase order and/or invoice number, to facilitate return goods authorization. For any new order placement, please provide a new purchase order to your customer\ncare representative.\n\nPlease maintain a copy of this letter for your records.\n\nMedtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality\nproblems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event\nReporting program via:\n-E-mail Medtronic at RS.MNSProdExperience", "product_quantity": "2911 units", "distribution_pattern": "Worldwide distribution. US nationwide, Albania,\nAlgeria,\nArgentina,\nArmenia,\nAustralia,\nAustria,\nBahrain,\nBangladesh,\nBelgium,\nPlurinational State Of Bolivia, \nBosnia And Herzegovina,\nBotswana,\nBrazil,\nBrunei Darussalam,\nBulgaria,\nCanada,\nCanary Islands,\nCayman Islands,\nChile,\nChina,\nColombia,\nCosta Rica,\nCroatia,\nCuracao,\nCyprus,\nCzech Republic,\nDenmark,\nDominican Republic,\nEcuador,\nEgypt,\nEl Salvador,\nFinland,\nFrance,\nGabon,\nGeorgia,\nGermany,\nGhana,\nGreece,\nGuatemala,\nHonduras,\nHong Kong,\nHungary,\nIceland,\nIndonesia,\n Islamic Republic Of Iran,\nIraq,\nIreland,\nIsrael,\nItaly,\nJamaica,\nJapan,\nJordan,\nKazakhstan,\n Republic Of Korea,\nKuwait,\nLao People's Democratic Republic,\nLatvia,\nLebanon,\nLibyan Arab Jamahiriya,\nLithuania,\nMacao,\nMalaysia,\nMalta,\nMauritania,\nMexico,\nMontenegro,\nNetherlands,\nNew Zealand,\nNicaragua,\nNigeria,\nNorth Macedonia,\nNorway,\nOman,\nPakistan,\nPanama,\nPapua New Guinea,\nParaguay,\nPeru,\nPhilippines,\nPoland,\nPortugal,\nPuerto Rico,\nQatar,\nRomania,\nRussian Federation,\nSaudi Arabia,\nSerbia,\nSingapore,\nSlovakia,\nSouth Africa,\nSouth Korea,\nSpain,\nSri Lanka,\nSudan,\nSweden,\nSwitzerland,\nTaiwan,\nThailand,\nTrinidad And Tobago,\nTunisia,\nTurkey,\nUkraine,\nUnited Arab Emirates,\nUnited Kingdom,\nUruguay,\nUzbekistan,\nViet Nam,\nand Yemen", "openfda": { "k_number": [ "K161992", "K913412", "K862513", "K905860", "K944595", "K150898", "K182265", "K904120", "K221918", "K914995", "K831396", "K855058", "K811288", "K033698", "K881616", "K981046", "K922936", "K042359", "K781768", "K870660", "K910853", "K760784", "K251598", "K021653", "K841442", "K820311", "K053107", "K980903", "K875205", "K061876", "K093968", "K110751", "K984053", "K823503", "K925810", "K992226", "K002476", "K102589", "K172759", "K172006", "K853366", "K861961", "K030698", "K904883", "K212641", "K172022", "K853365", "K760502", "K903844", "K992465", "K233445", "K171586", "K960159", "K231664", "K002970", "K970983", "K830894", "K171880", "K031303", "K063836", "K022554", "K024101", "K152152", "K181622", "K792007", "K992379", "K930222", "K955832", "K962990", "K831678", "K162437", "K862303", "K970658", "K241458", "K200807", "K823509", "K101381", "K791075", "K140722", "K760785", "K974739", "K083076", "K042481", "K932769", "K013488", "K963802", "K891456", "K040201", "K820312", "K082127", "K011030", "K081942", "K191684", "K884036", "K874508", "K853362", "K181301", "K090348", "K973525", "K122118", "K103003", "K042192", "K102961", "K902783", "K081773", "K935560", "K875287", "K920156", "K932429", "K243205", "K143111", "K261004", "K040943", "K984583", "K090342", "K060681", "K113526", "K152897", "K123554", "K221840", "K955265", "K981246", "K910938", "K000057", "K913842", "K951258", "K871752", "K243531", "K990256", "K992173", "K153041", "K032817", "K091346", "K161853", "K931989", "K242974", "K033850", "K161605", "K033017", "K050739", "K041296", "K971799", "K924600", "K864676", "K971511", "K862907", "K991502", "K200950", "K934545", "K974096", "K123524", "K243552", "K141687", "K853363", "K021196", "K030081", "K853361", "K181902", "K073139", "K021644", "K853364", "K911410", "K072929", "K172537", "K782105", "K192289", "K141227", "K894072", "K222422", "K190174", "K960435", "K042558", "K800168", "K233448", "K873247", "K042825", "K000514", "K012052", "K820247", "K871685", "K030289", "K970578", "K062599", "K250636", "K853215", "K954021", "K061568", "K902257", "K053350", "K973774", "K900676", "K031097", "K062009", "K854049", "K853371", "K040021", "K242003", "K854474", "K895524", "K980778", "K944222", "K112156", "K921936", "K760501", "K961859", "K971617", "K883114", "K802586", "K964371", "K092395", "K024040", "K223603", "K954285", "K091328", "K041992", "K091312", "K120559", "K896167", "K911433", "K974708", "K834593", "K892215", "K792005", "K962097", "K790849", "K110206", "K853369", "K843132", "K192266", "K042465", "K152700", "K221694", "K791076", "K222471", "K974726", "K803257", "K170599", "K080168", "K922941", "K003564", "K990660", "K042198", "K121248", "K913636", "K030468", "K972994", "K243676", "K020667", "K110560", "K052386", "K991429", "K861377", "K033704", "K252514", "K223330", "K790126", "K964923", "K172035", "K964386" ], "registration_number": [ "3008791915", "2030624", "9612164", "8043817", "2953359", "3004056227", "1047843", "3015151147", "3013557562", "1450662", "3007156625", "1836324", "3008087383", "9612501", "3013944123", "9617601", "2024024", "2648988", "3014334038", "3007544634", "1722746", "3003418325", "3044156918", "3006240422", "3008102042", "3010273872", "3043513133", "3004721439", "2023988", "3018094310", "3031571464", "2523553", "3008114965", "3015865915", "3012507533", "3010408671", "1721983", "3001587388", "3016577622", "3004530184", "3030733800", "1720929", "3015462837", "9611827", "3028006458", "2029275", "3013886523", "3014507028", "3016678045", "2916714", "3024673", "2530808", "3003477135", "1422634", "2032112", "3012421607", "1220477", "3004593495", "1221051", "3015531529", "3011689956", "3014522419", "3017636737", "9611274", "3033728927", "3003542872", "9610612", "3006697299", "1219114", "3006611221", "2011171" ], "fei_number": [ "3002806434", "3008791915", "1000306431", "3000206435", "3008133910", "3004056227", "3015151147", "3013557562", "1047843", "1450662", "1000306216", "3008087383", "3013944123", "2024024", "3003495548", "3014334038", "3007544634", "3002808043", "3003418325", "3044156918", "3043513133", "3010273872", "3004721439", "2023988", "3018094310", "1000064530", "1000514656", "3031571464", "2523553", "3008114965", "1000522098", "3015865915", "3010408671", "3012507533", "3001587388", "3016577622", "3004530184", "3030733800", "3002807634", "1720929", "3015462837", "3028006458", "3003477135", "3002924544", "3013886523", "3014507028", "3016678045", "2916714", "3024673", "3002807421", "3002806315", "3004593495", "3012421607", "1220477", "3003094575", "1221051", "3015531529", "3011689956", "3014522419", "3017636737", "3033728927", "3003076831", "3003542872", "3006697299", "3000204775", "1219114", "3002534070", "3002998595", "2011171", "3000215205" ], "device_name": "Shunt, Central Nervous System And Components", "medical_specialty_description": "Neurology", "regulation_number": "882.5550", "device_class": "2" } } ] }