COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI - none Lot Numbers - All lots within expiry
- 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:
- AtriCure, Inc.
- Reason for Recall:
- There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Product Codes/Lot Numbers:
UDI - none Lot Numbers - All lots within expiry
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0830-2019
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