Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Class I - DangerousWhat Should You Do?
- Check if you have this product: lots: VA15GPJ, VA15K3N, VA15K7K
- 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:
- Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Product Codes/Lot Numbers:
lots: VA15GPJ, VA15K3N, VA15K7K
Distribution:
Distributed in: US, AR, CA, FL, IL, MD, MO, NE, NY, OH, TN, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2602-2016
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