Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product…
Medical device recall Z-2431-2018. Published in FDA’s Enforcement Report on Jul 25, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 25, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 10,800 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
10,800 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: (a) 977D160: VA1M3MM002 VA1M3MM003 VA1M3MM004 VA1M3MM005 VA1M3MM006 VA1M3MM007 VA1M3MM008 VA1M3MM009 VA1M3MM010 VA1M3MM011 VA1M3MM012 VA1M3MM013 VA1M3MM014 VA1M3MM015 VA1M3MM016 VA1M3MM017 VA1M3MM018 VA1M3MM019 VA1M3MM020…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 126,931 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 25, 2018.
- FDA classified it on Jul 13, 2018.
- FDA’s Enforcement Report published it on Jul 25, 2018.
- FDA terminated it on Dec 11, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neuromodulation, of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 126,931 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.