# FDA recall Z-3294-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-08-01.

## Product

AGILE ESO FC RMV 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): M00517800

## 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

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

## Key facts

- **Recall number:** Z-3294-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-01
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3294-2024

## Citation

> AI Analytics. FDA recall Z-3294-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3294-2024. Source: US FDA. Licensed CC0.

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