Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vercise Deep Brain Stimulation Systems Surgical Implant Manual Recalled by Boston Scientific Neuromodulation Corporation Due to Wire break(s) have occurred in rechargeable deep brain...

Date: July 8, 2025
Company: Boston Scientific Neuromodulation Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Neuromodulation Corporation directly.

Affected Products

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Quantity: 25,260

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Neuromodulation Corporation

Boston Scientific Neuromodulation Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report