Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-3289-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

AGILE ESO OTW PC 23MM X 12.0CM 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): M00517730

Product Classification:

Class II

Date Initiated: August 1, 2024

Date Posted: October 2, 2024

Recall Number: Z-3289-2024

Event ID: 95124

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.

Status: Ongoing

Product Quantity: 17 units

Code Information:

GTIN: 00191506006600 Lot Numbers: 33005086

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Voluntary or Mandated:

Voluntary: Firm initiated