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Recall Observatory FDA recall evidence

Device product

WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered 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): M00516730

Z-3278-2024

August 01, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95124
Status
Ongoing
Classification
Class II
Quantity
364 units
Official record key
device-enforcement:Z-3278-2024

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: 08714729778066 Lot Numbers: 32770264, 32779262, 32799929, 32799930, 32809367, 32927194, 32946077, 32976902, 32977680, 32977681, 33017674, 33036450 33036451, 33045963, 33064554, 33064555, 33085586, 33130671, 33130672, 33195044, 33195045, 33214280, 33218599, 33266647

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.