VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348
- 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:
- LivaNova USA Inc
- Reason for Recall:
- During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Product Codes/Lot Numbers:
Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0535-2021
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