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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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,
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Neurosurgery
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1117-2021

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