Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3276-2024 — WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- 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

U.S. FDA — Device Enforcement · United States · 2024-08-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3276-2024
Date of alert: 2024-08-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 08714729778042

Reported risk: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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