--- title: "Boston Scientific Neuromodulation Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Boston Scientific Neuromodulation Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/boston-scientific-neuromodulation-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Boston Scientific Neuromodulation Corporation recall records **12** reported ongoing 12 records in this archive. Latest source date Jun 17, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 17, 2026 FDA device enforcement ### [INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spi...](https://isitonrecall.com/recall/fda-device-z-2879-2026-infinion-cx-lead-kit-50cm-model-sc-2317-50-material-m365sc2317500-infinion-cx-lead-kit-70cm-model-sc/) Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. Class I Reported ongoing Distribution: US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil,... [Official source for INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2879-2026%22) Apr 29, 2026 FDA device enforcement ### [Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga...](https://isitonrecall.com/recall/fda-device-z-2402-2026-boston-scientific-csk-electrodes-ref-csk-tc10-csk-electrode-stainless-steel-10-cm-x-28-ga-0-36-mm-re/) Reusable electrodes may not meet expected performance levels. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. [Official source for Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2402-2026%22) Apr 29, 2026 FDA device enforcement ### [Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN...](https://isitonrecall.com/recall/fda-device-z-2403-2026-boston-scientific-tcn-electrodes-ref-tcn-5-tcn-electrode-nitinol-5-cm-x-0-45-mm-0-0175-in-ref-tcn-10/) Reusable electrodes may not meet expected performance levels. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. [Official source for Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2403-2026%22) Apr 29, 2026 FDA device enforcement ### [Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180](https://isitonrecall.com/recall/fda-device-z-2404-2026-boston-scientific-model-sc-4318-clik-x-anchor-ref-m365sc43180/) Sterile anchors my lack sterility assurance. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK. [Official source for Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2404-2026%22) Apr 22, 2026 FDA device enforcement ### [Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/...](https://isitonrecall.com/recall/fda-device-z-2694-2026-intracept-access-instruments-description-ref-intracept-access-instruments-drill-rlv0035-intracept-ac/) Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA,... [Official source for Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRA...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2694-2026%22) Jul 8, 2025 FDA device enforcement ### [Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual](https://isitonrecall.com/recall/fda-device-z-2340-2025-burr-hole-cover-kit-ref-m365db4600c0-burr-hole-cover-spares-kit-ref-m365db4605c0-components-of-verci/) Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may requi... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA,... [Official source for Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2340-2025%22) Jul 8, 2025 FDA device enforcement ### [Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09](https://isitonrecall.com/recall/fda-device-z-2558-2025-vercise-deep-brain-stimulation-systems-surgical-implant-manual-document-number-92328632-09/) Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience h... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA,... [Official source for Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2558-2025%22) Jun 6, 2025 FDA device enforcement ### [Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 S...](https://isitonrecall.com/recall/fda-device-z-2485-2025-superion-ids-kit-superion-indirect-decompression-system-8mm-vf-implant-101-9808-00884662000529-super/) As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device. Class II Reported ongoing Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, N... [Official source for Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2485-2025%22) Jul 17, 2024 FDA device enforcement ### [WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320](https://isitonrecall.com/recall/fda-device-z-2617-2024-wavewriter-alpha-model-sc-1216-16-ipg-kit-ref-m365sc12160-model-sc-1232-32-ipg-kit-ref-m365sc12320/) Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy... Class II Reported ongoing Distribution: Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, ... [Official source for WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2617-2024%22) Apr 18, 2024 FDA device enforcement ### [Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320](https://isitonrecall.com/recall/fda-device-z-1890-2024-vercise-genus-deep-brain-stimulation-dbs-implantable-pulse-generator-ipg-r16-ipg-kit-ref-m365db12160/) Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, tr... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV,... [Official source for Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M36...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1890-2024%22) May 12, 2023 FDA device enforcement ### [Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Te...](https://isitonrecall.com/recall/fda-device-z-1972-2023-driver-instrument-part-of-the-superion-indirect-decompression-system-ref-102-9800-used-with-the-supe/) Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant locatio... Class II Reported ongoing Distribution: US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, M... [Official source for Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with t...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1972-2023%22) Oct 12, 2022 FDA device enforcement ### [Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm](https://isitonrecall.com/recall/fda-device-z-0230-2023-superion-indirect-decompression-system-ids-model-numbers-and-size-101-9808-8mm-01-9812-12mm-101-9814/) Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implan... Class II Reported ongoing Distribution: U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, ... [Official source for Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0230-2023%22) ## Reasons in these listed records - Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. - Reusable electrodes may not meet expected performance levels. - Sterile anchors my lack sterility assurance. - Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. These examples come from this result page and are not a ranking of every recall reason. ## Checking Boston Scientific Neuromodulation Corporation ### Is there a recall on boston scientific neuromodulation corporation right now? This archive contains 12 records, including 12 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Boston Scientific Neuromodulation Corporation](https://isitonrecall.com/check/?q=Boston%20Scientific%20Neuromodulation%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)