🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 8, 2025 Boston Scientific Neuromodulation Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Neuromodulation Corporation
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2558-2025

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