Z-3285-2024 Class II Ongoing
FDA device recall Z-3285-2024 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: 305 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2024
- Initiation Date
- Aug 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305 units
Product Description
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- 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): M00516940
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: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3285-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026