Boston Scientific Neuromodulation Recalls

August 12, 2026Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,

Hazard: 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.

July 15, 2026Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMEN

Hazard: 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.

June 17, 2026Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Hazard: Sterile anchors my lack sterility assurance.

June 17, 2026Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec

Hazard: Reusable electrodes may not meet expected performance levels.

June 17, 2026Medical DevicesFDA

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: CSK-TC10

Hazard: Reusable electrodes may not meet expected performance levels.

September 24, 2025Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Hazard: 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 high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

September 10, 2025Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect

Hazard: 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.

August 27, 2025Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu

Hazard: 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 require additional surgery.

August 21, 2024Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

Hazard: 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 turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

June 5, 2024Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K

Hazard: 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, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

June 21, 2023Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect De

Hazard: 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 location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

November 23, 2022Medical DevicesFDA

Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14m

Hazard: 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 implantation.