Boston Scientific Neuromodulation recalls
11 official recalls and safety alerts involving Boston Scientific Neuromodulation since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Boston Scientific Neuromodulation or the relevant agency.
- 2026-08-12
USBoston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model:…
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,…
FDA · DeviceBoston Scientific Neuromodulation CorporationUS: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain,…Official notice →- 2026-07-15
- US
Boston Scientific Neuromodulation Corporation recalls Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS…
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.
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of NJ, WI, MI,…Official notice → - 2026-06-17
- US
Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.Official notice → - US
Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:…
Reusable electrodes may not meet expected performance levels.
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide distribution - US Nationwide and the countries of PE, MX, PR, CO,…Official notice → - 2025-09-24
- US
Boston Scientific Neuromodulation Corporation recalls 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…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of MN, FL, CO,…Official notice → - 2025-09-10
- US
Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect…
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…
FDA · DeviceBoston Scientific Neuromodulation CorporationU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2025-08-27
- US
Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep…
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…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of MN, FL, CO,…Official notice → - 2024-08-21
- US
Boston Scientific Neuromodulation Corporation recalls 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…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC,…Official notice → - 2024-06-05
- US
Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32…
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…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of TX, WA, MT,…Official notice → - 2023-06-21
- US
Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion…
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…
FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK,…Official notice → - 2022-11-23
- US
Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
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…
FDA · DeviceBoston Scientific Neuromodulation CorporationU.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL,…Official notice →