WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- 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): M00516740
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648
- 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 ESOPHAGEAL FC 23/28MMX12CM- 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): M00516740
Product Codes/Lot Numbers:
GTIN: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3279-2024
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