AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
- 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 a component failure of the device which could necessitate medical intervention.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Product Codes/Lot Numbers:
Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0377-2017
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