Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729905318/Lot # 35107836
- 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:
- Sterile anchors my lack sterility assurance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Product Codes/Lot Numbers:
GTIN: 08714729905318/Lot # 35107836
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2404-2026
Related Recalls
Reusable electrodes may not meet expected performance levels.
Reusable electrodes may not meet expected performance levels.
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.