Class 2 Device Recall Medtronic PS Medical CSFFlow Control Valves

• Date Initiated by Firm: January 11, 2021
• Create Date: February 12, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1117-2021
• Recall Event ID: 87157
• 510(K)Number: K792007 K841442 K951258 K873247 K831678
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• 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 27553 M CSF-FLOW CNTRL SM EXTR MP; 27643M - SHUNT 27643M ASSY SM PCATH130CM MED; 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE; 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP; 42314- VALVE 42314 SM CONTOURED MED PRESS IMP; 42316 - VALVE 42316 SM CONTOURED HIGH PRESS; 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP; 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP; 42326 - VALVE 42326 CONT HIGH PRESS IMP; 42410 - VALVE 42410 ULTRA SMALL LOW-LOW; 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP; 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP; 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP; 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP; 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP; 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP; 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP; 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM; 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P; 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P; 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P; 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM; 46644 - SHUNT 46644 ASSY REG MED C/P-90CM; 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM; 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO; 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME; 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI; 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L; 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M; 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H; 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW; 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED; 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH; 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW; 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED; 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW; 92322 - VALVE 92322 CSF CONT REG LOW BIO; 92324 - VALVE 92324 CSF CONT REG MED BIO
• Code Information: 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,
• 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: 20,817 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 = P-S MEDICAL; 510(K)s with Product Code = JXG and Original Applicant = PUDENZ-SCHULTE MEDICAL RESEARCH CORP.