Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c)…
Medical device recall Z-2432-2018. 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
- 8182 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) 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.
8182 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: (a) 977A160: VA1LT6B001 VA1LT6B003 VA1LT6B004 VA1LT6B005 VA1LT6B006 VA1LT6B007 VA1LT6B008 VA1LT6B009 VA1LT6B010 VA1LT6B011 VA1LT6B012 VA1LT6B013 VA1LT6B014 VA1LT6B015 VA1LT6B017 VA1LT6B019 VA1LT6B020 VA1LT6B021 VA1LT6B022…
Every code shown here, 1,991 characters
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…
FDA’s list runs to 95,576 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 95,576 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
-
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.