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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Neurosurgery: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

Agency Publication Date: February 12, 2021
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Affected Products

Product: Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA R

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

Lot Numbers:
numbers
Product: Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II RE

Lot numbers for the affected CFNs: 0219498492, 0219471229, 0218700308, 0219498495, 0220423969, 0219378043, 0219802947, 0219395919, 0219395920, 0219395921, 0219471351, 0219470063, 0219470064, 0219471352, 0219127878, 0219127879, 0219127880, 0219550965, 0219551126, 0219551128, 0219551134, 0219127871, 0219127872, 0219127873, 0219127874, 0219127875, 0219127876, 0219480196, 0219480197, 0219480199, 0219480200, 0219499010, 0219551136, 0219551138, 0219551139, 0219551140, 0219471237, 0219931727, 0218700307, 0219267902, 0219471227, 0219931726, 0219467660, 0219467661, 0219467663, 0217207127, 0217207128, 0218226186, 0218247716, 0218287189, 0218605901, 0218605902, 0218609097, 0218609100, 0218609101, 0219171583, 0219171709, 0219352151, 0219352152, 0219480334, 0219480335, 0219497185, 0219497646, 0219497661, 0217205762, 0217205763, 0217207129, 0218226204, 0218226205, 0218287187, 0218287188, 0218287201, 0218396013, 0218415313, 0218415314, 0218415315, 0218609102, 0218609103, 0218609104, 0218609105, 0218609586, 0218609587, 0219081907, 0219115460, 0219115461, 0219307371, 0219307372, 0219352155,, 0219352157, 0219396250, 0219396252, 0219396254, 0219396255, 0219479762, 0219479763, 0219497751, 0219497755, 0218807819, 0219309515, 0219815331, 0220314446, 0220314447, 0220393226, 0220393227, 0216868584, 0217254777, 0217254778, 0217255248, 0217778039,, 0217778040, 0217778041, 0217817029, 0217817030, 0217817031, 0217817032, 0217817033, 0217971140, 0217971141, 0218033642, 0218033643, 0218033644, 0218033645, 0218034266, 0218034267, 0218286596, 0218286597, 0218286598, 0218286599, 0218416085, 0218605889, 0218605890, 0218605891, 0218605892, 0218605893, 0218605894, 0218609602, 0218609603, 0218609604, 0218639469, 0218639470, 0218639471, 0218639472, 0218787024, 0218787025, 0218787926, 0218787927, 0218787928, 0218787934, 0218873198, 0218873200, 0218873201, 0218873202, 0218964967, 0219053149, 0219071024, 0219103301, 0219497757, 0219497758, 0219497759, 0219497760, 0219497761, 0216105046, 0216105047, 0216105052, 0216105053, 0216259301, 0216259302, 0216362463, 0216362464, 0216362467, 0216363865, 0216418659, 0216418660, 0216513862, 0216513864, 0216579072, 0216579074, 0216666644, 0216729340, 0216732201, 0216732202, 0216732203, 0216732204, 0216732205, 0216733948, 0216821015, 0216821121, 0216821122, 0216821123, 0216821138, 0216821139, 0216868349, 0216868350, 0216868351, 0216868352, 0216868355, 0216868356, 0216868357, 0216868358, 0216868359, 0216868360, 0216868581, 0216868582, 0216868583, 0217254779, 0217254780, 0217254781, 0217254782, 0217254783, 0217254784, 0217254785, 0217255246, 0217255247, 0217260220, 0217260221, 0217260969, 0217260970, 0217778042, 0217778043, 0217817034, 0217817035, 0217817036, 0217817037, 0217817038, 0217817039, 0217817040, 0217923546, 0217923549, 0217923550, 0217923551, 0217923552, 0217923555, 0217971129, 0217971131, 0217971134, 0217971135, 0217971136, 0217971137, 0217971138, 0217971139, 0218033424, 0218033629, 0218033630, 0218033631, 0218033632, 0218033633, 0218033634, 0218033635, 0218033636, 0218033637, 0218033638, 0218033639, 0218033640, 0218033641, 0218034268, 0218286600, 0218286601, 0218286602, 0218286603, 0218286604, 0218286605, 0218287186, 0218287199, 0218287200, 0218417806, 0218417807, 0218417808, 0218417809, 0218417810, 0218417811, 0218417812, 0218605895, 0218605896, 0218605897, 0218605899, 0218605900, 0218609594, 0218609595, 0218609596, 0218609599, 0218609600, 0218610066, 0218639473, 0218639474, 0218639475, 0218639476, 0218639477, 0218639478, 0218964983, 0219000135, 0219000143, 0219081908, 0219103305, 0219115462, 0219115463, 0219118937,, 0219123053, 0219128329, 0219307369, 0219307370, 0219395719, 0219395720, 0219395721, 0219395723, 0219395724, 0219395725, 0219480328, 0219480329, 0219480330, 0219480331, 0219480332, 0219480333, 0219497762, 0219497763, 0219497764, 0220440998, 0220440999, 0219467664, 0219467665, 0219468526, 0220040131, 0220048557, 0220075411, 0220141393, 0220262093, 0220355866, 0220355867, 0219332742, 0219332743, 0220075412, 0220121098, 0220141394, 0220166866, 0220328424, 0219498721, 0217268265, 0218808947, 0220285340, 0219498725, 0220059296, 0220400355, 0219354861, 0219929565, 0220217121, 0220278246, 0219132084, 0219132085, 0219132126, 0220288366, 0219123889, 0219330677, 0219123853, 0219123854,

Lot Numbers:
numbers
Product: Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 2

Lot numbers for the affected CFNs: 0219278853, 0219278854, 0220099072, 0219278855, 0219278856, 0219768090, 0219768091, 0219798970, 0219798971, 0219798972, 0220010048, 0220112693, 0220141392, 0219802495, 0219802494, 0219583129, 0220286100, 0218796592, 0219952709, 0218806424, 0219316930, 0220280248, 0220286709, 0219480202, 0219802492, 0218045303, 0218045304, 0218045527, 0218408997, 0218408998, 0218408999, 0218590082, 0218721471, 0218721472, 0219234579, 0219497114, 0219648109, 0219978722, 0220100564, 0220444728, 0217286212, 0217286213, 0217286214, 0217706616, 0217706621, 0217706622, 0217706623, 0217962420, 0217962421, 0217971628, 0217971633, 0218409003, 0218409004, 0218409005, 0218590077, 0218590078, 0218590079, 0218590080, 0218590081, 0218720196, 0218720202, 0218972089, 0218972090, 0219234580, 0219312365, 0219375930, 0219761087, 0220122285, 0220124886, 0220124887, 0220124888, 0220272309, 0220444084, 0220444085, 0220444726, 0217286211, 0217706612, 0217962419, 0217971634, 0217971635, 0218424703, 0218424704, 0218590071, 0217286216, 0217962409, 0217962418, 0217971637, 0217971638, 0218424701, 0218424702, 0217962422, 0217962423, 0217962424, 0217962425, 0218402220, 0218408987, 0218408988, 0218408989, 0218408990, 0218408991, 0218408992, 0218408993, 0218408994, 0218408996, 0218590073, 0218590074, 0218590075, 0218590076, 0218720244, 0218720287, 0218720289, 0219234581, 0219234582, 0219320159, 0219320160, 0219320162, 0219320163, 0219574223, 0219761097, 0219910255, 0219910256, 0220324658, 0220530229, 0218590084, 0218590085, 0219312364, 0219978742, 0220444083, 0219277363, 0219278519, 0219278520, 0219278516, 0219278517, 0219374313, 0219374314, 0219733266, 0219733267, 0218605545, 0218605686, 0218605539, 0218605540, 0218605541, 0218605542, 0218605543, 0218605544, 0219375125, 0219375926, 0219375927, 0219375928, 0219375929, 0219438310, 0219761086, 0219910252, 0219910253, 0220444735, 0218605538, 0218605536, 0218605537, 0220280189, 0218605688, 0218605689, 0218605690, 0218605691, 0218978999, 0218979001, 0218979002, 0218979003, 0218979005, 0218979086, 0218979087, 0219123064, 0219123586, 0219123588, 0219123589, 0219422860, 0219422861, 0219465702, 0219465703, 0219761093, 0219761094, 0219761095, 0219761096, 0220272311, 0218605687, 0219579789, 0219894795, 0219279151, 0220288369, 0219278874, 0219894797, 0220201981, 0220602456, 0220285339, 0219279160, 0219278877, 0219278878, 0219278879, 0219278880, 0219694364, 0220075413, 0220075414, 0219354851, 0219354852, 0219354853, 0219354854, 0220114768, 0220398628, 0219278737, 0219278738, 0219278739, 0219278740, 0219708098, 0219708099, 0219851768, 0219851769, 0219851770, 0219981926, 0220053812, 0220053813, 0220081704, 0220085756, 0220085757, 0220099077, 0220099078, 0220134024, 0220134025, 0220156462, 0220156463, 0220173989, 0220285673, 0220352833, 0220398644, 0219278736, 0220393229, 0219278734, 0219278735, 0220011262, 0219278731, 0219278733, 0219769315, 0219769316, 0219851771, 0219851772, 0219851773, 0220305451, 0220622330, 0220680023, 0219354855, 0219927060, 0220546836, 0219278730, 0220011259, 0220397733, 0219127889, 0219128109, 0219128111, 0219128112, 0219128113, 0219128115, 0219128117, 0219128118, 0219128119, 0219128120, 0219128121, 0219917405, 0220009922, 0220009923, 0220040136, 0220059298, 0220059299, 0220099075, 0220099076, 0220102737, 0220118172, 0220156744, 0220156745, 0220201972, 0220201979, 0220217393, 0220249127, 0220397688, 0220397689, 0220397691, 0220397699, 0220397703, 0220400359, 0220702309, 0219969972, 0219272921, 0219950183, 0219127462, 0219127463, 0219127464, 0219127465, 0219127886, 0219127887, 0219127890, 0219127891, 0219127892, 0219127893, 0219127894, 0219127895, 0219127896, 0219127897, 0219127898, 0219698790, 0219698792, 0219721377, 0219721378, 0219721379, 0219721380, 0219721381, 0219917404, 0219988521, 0220075419, 0220141390, 0220141391, 0220141405, 0220141706, 0220156743, 0220173988, 0220249134, 0220255058, 0220262090, 0220285669, 0220285670, 0220285672, 0220301203, 0220324602, 0220330904, 0220360618, 0220637047, 0219278729, 0219698786, 0220522999, 0219067893, 0219067894, 0220400350,

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87157
Status: Active
Manufacturer: Medtronic Neurosurgery
Manufactured In: United States
Units Affected: 3 products (2911 units; 22,528 units; 20,817 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.