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boston scientific neuromodulation corporation

6 recalls on record

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Boston Scientific Neuromodulation Corporation — 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 STE

Reusable electrodes may not meet expected performance levels.

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

Sterile anchors my lack sterility assurance.

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Boston Scientific Neuromodulation Corporation — 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

Reusable electrodes may not meet expected performance levels.

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Boston Scientific Neuromodulation Corporation — Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surg

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.

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Boston Scientific Neuromodulation Corporation — 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 high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

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Boston Scientific Neuromodulation Corporation — Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Im

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.