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
Reported: October 2, 2024 Initiated: August 1, 2024 #Z-3279-2024
Product 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
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 507 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boston Scientific Corporation. Units affected: 507 units.
Why was this product recalled? ▼
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3279-2024.
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