FDAFDA · Food and drugs·Recall number Z-2431-2018
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.
Published July 25, 2018 · Recall initiated: May 25, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Worldwide
- Lot
- 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 0214355725 0214355726 0214355727 0214355728 0214355729 0214355730 0214355731 0214355732 0214355733 0214355734 0214355735 0214355736 0214360663 0214360664 0214360665 0214370973 0214398281 0214398282 0214398284 0214398285 0214398286 0214398288 0214398290 0214398292 0214398293 0214398295 0214398296 0214398298 0214398300 0214398302 0214430302 0214430303 0214434011 0214434012 0214447462 0214447463 0214447464 0214447465 0214469358 0214469360 0214469441 0214469468 0214469469 0214469470 0214469471 0214469472 0214469473 0214469475 0214469476 0214469477 0214469478 0214469502 0214469503 0214469504 0214469505 0214469506 0214469507 0214469508 0214469509 0214469510 0214469511 0214469512 0214469513 0214469514 0214469515 0214469516 0214469517 0214469518 0214469519 0214469520 0214469541 0214469542 0214469543 0214469544 0214469545 0214469546 0214469547 0214469548 0214469549 0214469550 0214469551 0214469552 0214469553 0214469554 0214494050 0214494051 0214494052 0214503002 0214503003 0214503004 0214528437 0214528438 0214528439 0214528440 0214528661 0214537125 0214537126 0214537128 0214537129 0214537130 0214537131 0214537132 0214537135 0214548589 0214548590 0214548591 0214548592 0214548593 0214548594 0214573905 0214573906 0214573907 0214573908 0214573909 0214573910 0214573911 0214573912 0214573913 0214573914 0214573915 0214573916 0214573917 0214582105 0214582106 0214582107 0214582108 0214582109 0214590247 0214590248 0214617866 0214617867 0214617868 0214618298 0214618299 0214621257 0214641651 0214641652 0214647590 0214701499 0214751681 0214751682 0214751683 0214751684 0214805685 0214805686 0214805687 0214805688 0214805689 0214805690 0214805691 0214805699 0214805700 0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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