WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516910
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729765257 Lot Numbers: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516910
Product Codes/Lot Numbers:
GTIN: 08714729765257 Lot Numbers: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3282-2024
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