Class 2 Device Recall Medtronic PS Medical Strata II Valve and Shunt Assemblies

• Date Initiated by Firm: January 11, 2021
• Create Date: February 12, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1116-2021
• Recall Event ID: 87157
• 510(K)Number: K060681 K042465 K083076 K123524 K033850
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• 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 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,
• Code Information: 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,
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 5290 California Ave; Irvine CA 92617-3073
• Manufacturer 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
• FDA Determined Cause: 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; 1.¿ Be aware that radiopaque marker visualization with impacted devices under radiographic imaging may be insufficient to determine the pressure level and/or flow direction. In these situations, alternative methods for this determination should be considered, if deemed necessary per clinical discretion. 2.¿ Share this information within your organization to healthcare professionals who monitor patients implanted with these devices. 3.If desired, radiographic imaging of packaged devices may be conducted pre-operatively to determine marker radiopacity. However, marker visibility of packaged devices under radiographic imaging may not be representative of marker visibility post-implant. 4. Complete and return the enclosed confirmation form to acknowledge receipt of this notification. Additional Information: Medtronic will honor the return of these products for full credit. If you require a return goods authorization, you can visit http://connect.medtronic.com to initiate your return that is less than 90 days old. For returns over 90 days old, please contact Customer Care directly at 1-800-874-5797. Please ensure that you reference FCA 2020- 12-08-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 care representative. Please maintain a copy of this letter for your records. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: -E-mail Medtronic at RS.MNSProdExperience
• Quantity in Commerce: 22,528 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JXG and Original Applicant = MEDTRONIC NEUROSURGERY