LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00763000274320, Serial Number VA2JV2V
- 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:
- Medtronic Neuromodulation
- Reason for Recall:
- There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Product Codes/Lot Numbers:
UDI/DI 00763000274320, Serial Number VA2JV2V
Distribution:
Distributed in: US, MO, FL, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0217-2024
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