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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 Neuromodulation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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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VA1M3MR003 VA1M3MR004 VA1M3MR005 VA1M3MR006 VA1M3MR007 VA1M3MR008 VA1M3MR009 VA1M3MR010 VA1M3MR011 VA1M3MR012 VA1M3MR013 VA1M3MR014 VA1M3MR015 VA1M3MR016 VA1M3MR017 VA1M3MR018 VA1M3MR019 VA1M3MR020 VA1M3MR021 VA1M3MR023 VA1M3MR024 VA1M3MR025 VA1M3MR026 VA1M3MR027 VA1M3MR028 VA1M3MR029 VA1M3MR030 VA1M3MR031 VA1M3MR032 VA1M3MR033 VA1M3MR034 VA1M3MR035 VA1M3MR036 VA1M3MR037 VA1M3MR038 VA1M3MR039 VA1M3MR040 VA1M3MR041 VA1M3MR042 VA1M3MR043 VA1M3MR044 VA1M3MR045 VA1M4ZJ001 VA1M4ZJ002 VA1M4ZJ004 VA1M4ZJ005 VA1M4ZJ006 VA1M4ZJ008 VA1M4ZJ009 VA1M4ZJ010 VA1M4ZJ011 VA1M4ZJ012 VA1M4ZJ013 VA1M4ZJ014 VA1M4ZJ015 VA1M4ZJ016 VA1M4ZJ017 VA1M4ZJ018 VA1M4ZJ019 VA1M4ZJ020 VA1M4ZJ021 VA1M4ZJ022 VA1M4ZJ023 VA1M4ZJ024 VA1M4ZJ025 VA1M4ZJ026 VA1M4ZJ027 VA1M4ZJ028 VA1M4ZJ029 VA1M4ZJ030 VA1M4ZJ031 VA1M4ZJ032 VA1M4ZJ033 VA1M4ZJ034 VA1M4ZJ035 VA1M4ZJ036 VA1M4ZJ037 VA1M4ZJ038 VA1M4
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2431-2018
Related Recalls
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic Neuromodulation
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Medtronic Neuromodulation
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.