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Recall Observatory FDA recall evidence

Device product

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 Material Number (UPN): M00516710

Z-3276-2024

August 01, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95124
Status
Ongoing
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-3276-2024

Official wording

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

Code information: GTIN: 08714729778042 Lot Numbers: 32779261, 32820237, 32906416, 33030432, 33077155, 33077156, 33094173, 33137309, 33137313, 33195043

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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