Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2558-2025.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2558-2025.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Boston Scientific Neuromodulation Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2558-2025.
Boston Scientific Neuromodulation Corporation
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Boston Scientific Neuromodulation Corporation Recall FAQ
Boston Scientific Neuromodulation Corporation is the subject of a medical implants safety report: Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09. The notice was published on July 8, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 25,260 units are potentially affected.