Z-3284-2024 Class II Ongoing
FDA device recall Z-3284-2024 was initiated by Boston Scientific Corporation on Aug 1, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 133 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2024
- Initiation Date
- Aug 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 133 units
Product Description
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- 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): M00516930
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Code Information
GTIN: 08714729765271 Lot Numbers: 32770265, 32799938, 32799939 32809371, 32809372, 32957301 33128874, 33156073, 33156074 33156075, 33156076, 33233491 33233492
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3284-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026