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

Medtronic PS Medical Cerebro Spinal Fluid recalled

Medtronic Neurosurgery is recalling Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following, distributed nationwide in the US. The recall was initiated on 11 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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,

Quantity recalled20,817 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-1117-2021
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 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

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: 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,

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

This product is part of a recall event; the main page for the event is Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts recalled.

Reported	Class	Recall	Company	Reason	Where
24 Feb 2021	CLASS II	Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts recalled	Medtronic Neurosurgery	Other	Nationwide
24 Feb 2021	CLASS II	Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control recalled	Medtronic Neurosurgery	Other	Nationwide

More recalls from Medtronic Neurosurgery

All 32

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Ventriculostomy Kit recalled by Medtronic Neurosurgery	Medtronic Neurosurgery	Other	Nationwide
25 Dec 2024Device	CLASS I	Becker External Drainage and Monitoring System recalled	Medtronic Neurosurgery	Packaging Defects	Nationwide
25 Dec 2024Device	CLASS I	Exacta External Drainage and Monitoring System recalled	Medtronic Neurosurgery	Packaging Defects	Nationwide
6 Mar 2024Device	CLASS I	Medtronic Duet External Drainage and Monitoring System recalled	Medtronic Neurosurgery	Other	Nationwide
6 Mar 2024Device	CLASS I	Medtronic Duet External Drainage and Monitoring System recalled	Medtronic Neurosurgery	Other	Nationwide

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide