FDA recall record · openFDA

Boston Scientific Neuromodulation Corporation

9 FDA recalls on record (2023–2026) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Reusable electrodes may not meet expected performance levels. 2

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole 1

As a result of a comprehensive product performance review it was determine that the device and instruments are not consi 1

Sterile anchors my lack sterility assurance. 1

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, 1

Recalls

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10 Class II 2026-04-29 Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 Class II 2026-04-29 Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec Class II 2026-04-29 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu Class II 2025-07-08 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Class II 2025-06-06 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 Class II 2025-07-08 WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 Class II 2024-07-17 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K Class II 2024-04-18 Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect De Class II 2023-05-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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