The FDA has posted 8 enforcement recalls from Boston Scientific Neuromodulation Corporation since 2025, including 1 Class I (most serious) recall. Most recent report: Aug 12, 2026.
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, i…
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.
Reusable electrodes may not meet expected performance levels.
Sterile anchors my lack sterility assurance.
Reusable electrodes may not meet expected performance levels.
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location.…
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels.…
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 del…
Firm name as filed with the FDA: “Boston Scientific Neuromodulation Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.