Z-3273-2024 Class II Ongoing
FDA device recall Z-3273-2024 was initiated by Boston Scientific Corporation on August 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: 115 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 units
Product Description
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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): M00516310
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: 08714729905561 Lot Numbers: 32858862, 32865977, 32898069, 32914769, 32985474, 33256092