FDA Enforcement Class II Ongoing

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 REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,

Recall: Z-1116-2021 · Reported February 24, 2021

Enforcement

Recall Number: Z-1116-2021
Event ID: 87157
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Medtronic Neurosurgery
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: February 24, 2021
Initiation Date: January 11, 2021
Classification Date: February 12, 2021
Address: 5290 California Ave, N/A, Irvine, CA, 92617-3073, United States

Description

Reason

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

Code Info

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,

Distribution

Worldwide distribution. US nationwide, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Plurinational State Of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Islamic Republic Of Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Republic Of Korea, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Malta, Mauritania, Mexico, Montenegro, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen

Quantity

22,528 units