Exact FDA event identifier

Event 80256

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 25, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtronic Neuromodulation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.

Z-2431-2018

Recall number: Z-2431-2018
Initiated: May 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Neuromodulation
Quantity: 10,800 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

Code information

Serial Numbers: (a) 977D160: VA1M3MM002 VA1M3MM003 VA1M3MM004 VA1M3MM005 VA1M3MM006 VA1M3MM007 VA1M3MM008 VA1M3MM009 VA1M3MM010 VA1M3MM011 VA1M3MM012 VA1M3MM013 VA1M3MM014 VA1M3MM015 VA1M3MM016 VA1M3MM017 VA1M3MM018 VA1M3MM019 VA1M3MM020 VA1M3MM021 VA1M3MM023 VA1M3MM024 VA1M3MM025 VA1M3MM026 VA1M3MM027 VA1M3MM028 VA1M3MM029 VA1M3MM030 VA1M3MM031 VA1M3MM032 VA1M3MM033 VA1M3MM036 VA1M3MM037 VA1M3MM038 VA1M3MM039 VA1M3MM041 VA1M3MM042 VA1M3MM044 VA1M3MP035 VA1M3MP037 VA1M3MP038 VA1M3MP039 VA1M3MP040 VA1M3MP041 VA1M3MP042 VA1M3MP043 VA1M3MP044 VA1M3MP045 VA1M3MQ003 VA1M3MQ012 VA1M3MQ014 VA1M3MQ018 VA1M3MQ023 VA1M3MQ025 VA1M3MQ026 VA1M3MQ027 VA1M3MQ028 VA1M3MQ029 VA1M3MQ030 VA1M3MQ038 VA1M3MQ039 VA1MSCR002 VA1MSCR003 VA1MSCR004 VA1MSCR005 VA1MSCR006 VA1MSCR007 VA1MSCR008 VA1MSCR009 VA1MSCR010 VA1MSCR011 VA1MSCR012 VA1MSCR013 VA1MSCR014 VA1MSCR015 VA1MSCR016 VA1MSCR017 VA1MSCR018 VA1MSCR019 VA1MSCR020 VA1MSCR021 VA1MSCR022 VA1MSCR023 VA1MSCR024 VA1MSCR025 VA1MSCR026 VA1MSCR027 VA1MSCR028 VA1MSCR029 VA1MSCR030 VA1MSCR031 VA1MSCR032 VA1MSCR033 VA1MSCR034 VA1MSCR035 VA1MSCR036 VA1MSCR037 VA1MSCR038 VA1MSCR039 VA1MSCR040 VA1MSCR041 VA1MSCR042 VA1MSCR043 VA1MSCR044 VA1MSCR045 VA1MTN7002 VA1MTN7003 VA1MTN7004 VA1MTN7005 VA1MTN7006 VA1MTN7007 VA1MTN7008 VA1MTN7009 VA1MTN7010 VA1MTN7011 VA1MTN7012 VA1MTN7013 VA1MTN7014 VA1MTN7015 VA1MTN7016 VA1MTN7017 VA1MTN7018 VA1MTN7019 VA1MTN7020 VA1MTN7021 VA1MTN7022 VA1MTN7023 VA1MTN7024 VA1MTN7025 VA1MTN7026 VA1MTN7027 VA1MTN7028 VA1MTN7029 VA1MTN7030 VA1MTN7031 VA1MTN7032 VA1MTN7033 VA1MTN7034 VA1MTN7035 VA1MTN7036 VA1MTN7037 VA1MTN7039 VA1MTN7040 VA1MTN7041 VA1MTN7042 VA1MTN7043 VA1MTN7044 VA1MTN7045 (b) 977D260: 0214355376 0214355377 0214355378 0214355379 0214355380 0214355701 0214355702 0214355703 0214355704 0214355705 0214355706 0214355707 0214355708 0214355709 0214355710 0214355711 0214355712 0214355713 0214355714 0214355715 0214355716 0214355717 0214355718 0214355719 0214355720 0214355721 0214355722 0214355723 0214355724 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Distribution pattern

Worldwide

device · product 2 of 2

Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.

Z-2432-2018

Recall number: Z-2432-2018
Initiated: May 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Neuromodulation
Quantity: 8182 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Serial Numbers: (a) 977A160: VA1LT6B001 VA1LT6B003 VA1LT6B004 VA1LT6B005 VA1LT6B006 VA1LT6B007 VA1LT6B008 VA1LT6B009 VA1LT6B010 VA1LT6B011 VA1LT6B012 VA1LT6B013 VA1LT6B014 VA1LT6B015 VA1LT6B017 VA1LT6B019 VA1LT6B020 VA1LT6B021 VA1LT6B022 VA1LT6B023 VA1LT6B024 VA1LT6B025 VA1LT6B026 VA1LT6B027 VA1LT6B028 VA1LT6B029 VA1LT6B030 VA1LT6B031 VA1LT6B032 VA1LT6B033 VA1LT6B035 VA1LT6B036 VA1LT6B037 VA1LT6B038 VA1LT6B039 VA1LT6B040 VA1LT6B041 VA1LT6B042 VA1LT6B043 VA1LT6B044 VA1LT6B045 VA1LVVU005 VA1LVVU006 VA1LVVU007 VA1LVVU009 VA1LVVU010 VA1LVVU011 VA1LVVU012 VA1LVVU013 VA1LVVU014 VA1LVVU015 VA1LVVU016 VA1LVVU017 VA1LVVU018 VA1LVVU019 VA1LVVU020 VA1LVVU021 VA1LVVU022 VA1LVVU023 VA1M1ZT001 VA1M1ZT002 VA1M1ZT003 VA1M1ZT004 VA1M1ZT007 VA1M1ZT008 VA1M1ZT009 VA1M1ZT010 VA1M1ZT011 VA1M1ZT012 VA1M1ZT016 VA1M1ZT017 VA1M1ZT019 VA1M1ZT020 VA1M1ZT021 VA1M1ZT022 VA1M1ZT025 VA1MK0P001 VA1MK0P002 VA1MK0P003 VA1MK0P004 VA1MK0P005 VA1MP8Q001 VA1MP8Q002 VA1MP8Q003 VA1MP8Q004 VA1MP8Q006 VA1MP8Q007 VA1MP8Q008 VA1MP8Q010 VA1MP8Q011 VA1MP8Q012 VA1MP8Q013 VA1MP8Q014 VA1MP8Q015 VA1MP8Q021 VA1MP8Q022 VA1MP8Q023 VA1MP8Q024 VA1MP8Q025 VA1MP8Q026 VA1MP8Q027 VA1MP8Q028 VA1MP8Q029 VA1MP8Q030 VA1MP8Q031 VA1MP8Q032 VA1MP8Q033 VA1MP8Q034 VA1MP8Q035 VA1MP8Q036 VA1MP8Q037 VA1MP8Q038 VA1MP8Q039 VA1MP8Q040 VA1MPKY001 VA1MPKY002 VA1MPKY003 VA1MPKY004 VA1MPKY005 VA1N54C010 VA1NAMG003 VA1NAMG004 VA1NAMG010 VA1NAMG016 VA1NAMG036 VA1NAMG038 VA1NAMG039 VA1NAMG040 VA1NAMG044 VA1NAMG045 VA1P9C0001 VA1P9C0002 VA1P9C0005 VA1P9C0012 VA1P9C0014 VA1P9C0015 VA1P9C0016 VA1P9C0020 VA1P9C0025 VA1P9C0029 (b) 977A175: VA1MNGH001 VA1MNGH007 VA1MNGH008 VA1MNGH009 VA1MNGH010 VA1MNGH011 VA1MNGH012 VA1MNGH013 VA1MNGH014 VA1MNGH015 VA1MNGH016 VA1MNGH017 VA1MNGH018 VA1MNGH027 VA1MNGH028 VA1MNGH029 VA1NJZ9005 VA1NJZ9013 VA1NJZ9014 VA1NJZ9023 VA1NJZ9024 VA1NJZ9025 (c) 977A190: 0214934194 0215017599 VA1MHF3001 VA1MHF3002 VA1MHF3003 VA1MHF3004 VA1MHF3005 VA1MHF3006 VA1MHF3007 VA1MHF3008 VA1MHF3009 VA1MHF3010 VA1MHF3011 VA1MHF3012 VA1MHF3013 VA1MHF3014 VA1NJ6Z037 (d) 977A260: 0214341392 0214341393 0214342261 0214342262 0214342263 0214342264 0214342265 0214342266 0214342267 0214342268 0214342269 0214342270 0214342271 0214342272 0214342273 0214342274 0214342275 0214342276 0214342277 0214342278 0214342279 0214342280 0214342281 0214346866 0214346867 0214346868 0214346869 0214346870 0214346871 0214346872 0214346873 0214346874 0214346959 0214346960 0214347001 0214347002 0214347381 0214347382 0214347383 0214349401 0214349402 0214349403 0214349404 0214349405 0214349406 0214479848 0214479850 0214479851 0214479852 0214479853 0214479854 0214479855 0214479856 0214479858 0214479859 0214479860 0214479881 0214479882 0214479884 0214479887 0214479888 0214479889 0214479890 0214479894 0214479895 0214479896 0214479897 0214479898 0214479899 0214479900 0214479901 0214479902 0214479904 0214479905 0214479906 0214479907 0214479908 0214479909 0214479911 0214479912 0214479913 0214479914 0214479915 0214479916 0214479917 0214486884 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VA1LK4C033 VA1LK4C034 VA1LK4C035 VA1LK4C036 VA1LK4C037 VA1LK4C038 VA1LK4C039 VA1LK4C040 VA1LK4C041 VA1LK4C042 VA1LK4C043 VA1LK4C044 VA1LK4C045 VA1LK4D001 VA1LK4D002 VA1LK4D003 VA1LK4D004 VA1LK4D005 VA1LK4D006 VA1LK4D008 VA1LK4D009 VA1LK4D010 VA1LK4D011 VA1LK4D012 VA1LK4D013 VA1LK4D014 VA1LK4D015 VA1LK4D016 VA1LK4D017 VA1LK4D020 VA1LK4D021 VA1LK4D022 VA1LK4D023 VA1LK4D024 VA1LK4D025 VA1LK4D026 VA1LK4D027 VA1LK4D028 VA1LK4D029 VA1LK4D030 VA1LK4D031 VA1LK4D032 VA1LK4D033 VA1LK4D034 VA1LK4D035 VA1LK4D036 VA1LK4D037 VA1LK4D038 VA1LK4D039 VA1LK4D040 VA1LK4D041 VA1LK4D042 VA1LK4D043 VA1LK4D044 VA1LK4D045 VA1LK4F001 VA1LK4F002 VA1LK4F003 VA1LK4F004 VA1LK4F005 VA1LK4F006 VA1LK4F007 VA1LK4F008 VA1LK4F009 VA1LK4F010 VA1LK4F011 VA1LK4F012 VA1LK4F013 VA1LK4F014 VA1LK4F015 VA1LK4F016 VA1LK4F017 VA1LK4F019 VA1LK4F021 VA1LK4F022 VA1LK4F023 VA1LK4F024 VA1LK4F025 VA1LK4F026 VA1LK4F027 VA1LK4F028 VA1LK4F029 VA1LK4F031 VA1LK4F033 VA1LK4F034 VA1LK4F035 VA1LK4F036 VA1LK4F037 VA1LK4F038 VA1LK4F039 VA1LK4F040 VA1LK4F041 VA1LK4F042 VA1LK4F043 VA1LK4F044 VA1LK4F045 VA1LLLV001 VA1LLLV002 VA1LLLV003 VA1LLLV004 VA1LLLV005 VA1LLLV006 VA1LLLV007 VA1LLLV008 VA1LLLV009 VA1LLLV010 VA1LLLV011 VA1LLLV012 VA1LLLV013 VA1LLLV014 VA1LLLV015 VA1LLLV016 VA1LLLV017 VA1LLLV018 VA1LLLV019 VA1LLLV020 VA1LLLV021 VA1LLLV022 VA1LLLV023 VA1LLLV024 VA1LLLV025 VA1LLLV026 VA1LLLV027 VA1LLLV028 VA1LLLV029 VA1LLLV030 VA1LLLV031 VA1LLLV032 VA1LLLV033 VA1LLLV034 VA1LLLV035 VA1LLLV036 VA1LLLV039 VA1LLLV040 VA1LLLV041 VA1LLLV042 VA1LLLV043 VA1LLLV044 VA1LLLV045 VA1LMM0001 VA1LMM0002 VA1LMM0003 VA1LMM0005 VA1LMM0007 VA1LMM0008 VA1LMM0009 VA1LMM0011 VA1LMM0013 VA1LMM0014 VA1LMM0015 VA1LMM0016 VA1LMM0017 VA1LMM0018 VA1LMM0019 VA1LMM0020 VA1LMM0021 VA1LMM0022 VA1LMM0023 VA1LMM0024 VA1LMM0025 VA1LMM0026 VA1LMM0027 VA1LMM0028 VA1LMM0029 VA1LMM0030 VA1LMM0031 VA1LMM0032 VA1LMM0033 VA1LMM0034 VA1LMM0035 VA1LMM0036 VA1LMM0037 VA1LMM0039 VA1LMM0040 VA1LMM0041 VA1LMM0043 VA1LMM0044 VA1LMM0045 VA1LMM1001 VA1LMM1002 VA1LMM1003 VA1LMM1004 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VA1MDL9015 VA1MDL9016 VA1MDL9017 VA1MDL9018 VA1MDL9019 VA1MDL9020 VA1MDL9021 VA1MDL9022 VA1MDL9023 VA1MDL9025 VA1MDL9026 VA1MDL9027 VA1MDL9028 VA1MDL9029 VA1MDL9030 VA1MDL9031 VA1MDL9032 VA1MDL9033 VA1MDL9034 VA1MDL9035 VA1MDL9036 VA1MDL9037 VA1MDL9038 VA1MDL9039 VA1MDL9040 VA1MDL9041 VA1MDL9042 VA1MDL9043 VA1MDL9044 VA1MDL9045 VA1MDLB001 VA1MDLB002 VA1MDLB003 VA1MDLB004 VA1MDLB005 VA1MDLB006 VA1MDLB007 VA1MDLB008 VA1MDLB009 VA1MDLB010 VA1MDLB011 VA1MDLB012 VA1MDLB013 VA1MDLB014 VA1MDLB015 VA1MDLB016 VA1MDLB017 VA1MDLB018 VA1MDLB019 VA1MDLB020 VA1MDLB021 VA1MDLB022 VA1MDLB024 VA1MDLB025 VA1MDLB026 VA1MDLB027 VA1MDLB028 VA1MDLB029 VA1MDLB031 VA1MDLB032 VA1MDLB033 VA1MDLB034 VA1MDLB035 VA1MDLB036 VA1MDLB038 VA1MDLB040 VA1MDLB041 VA1MDLB042 VA1MDLB043 VA1MDLB044 VA1MDLB045 VA1ME15001 VA1ME15002 VA1ME15003 VA1ME15004 VA1ME15005 VA1ME15006 VA1ME15007 VA1ME

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