Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Product Codes/Lot Numbers:
All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2340-2025
Related Recalls
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Boston Scientific Neuromodulation
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.
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.
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Boston Scientific Neuromodulation
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.