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Recall Observatory FDA recall evidence

Device product

WALLFLEX FC ESO STENT RMV 23X105MM- 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): M00516240

Z-3268-2024

August 01, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95124
Status
Ongoing
Classification
Class II
Quantity
146 units
Official record key
device-enforcement:Z-3268-2024

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: 08714729854500 Lot Numbers: 32867087, 32980849, 33014126, 33085585, 33128875, 33208047, 33233490, 33275533

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.