CLASS II ONGOING Device recall · Reported 24 Feb 2021 · FDA Enforcement Report

Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts recalled

Medtronic Neurosurgery is recalling Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts, distributed nationwide in the US. The recall was initiated on 11 Jan 2021 and the FDA has classified it as Class II.

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Lot, batch or date codesLot 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,

Quantity recalled22,528 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1116-2021
FDA event ID: 87157
Recalling firm: Medtronic Neurosurgery, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jan 2021
FDA classified: 12 Feb 2021
Reported: 24 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

11 Jan 2021	Recall initiated by company
12 Feb 2021	Classified by FDA	+32 days
24 Feb 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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,

Where it was distributed

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

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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,

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 87157

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24 Feb 2021	CLASS II	Medtronic PS Medical Cerebro Spinal Fluid recalled	Medtronic Neurosurgery	Other	Nationwide
24 Feb 2021	CLASS II	Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control recalled	Medtronic Neurosurgery	Other	Nationwide

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