Recall Z-3288-2024— Boston Scientific Corporation

Name: FDA recall Z-3288-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-01

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-08-01. It names one FDA 510(k) clearance: K233837. Product: AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW 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): M00517720. Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-08-01
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K233837 — Agile Esophageal Stent SystemBoston Scientific Corporation·cleared 2024-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW 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): M00517720

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.