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Recall Observatory FDA recall evidence

Device product

WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- 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): M00516740

Z-3279-2024

August 01, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95124
Status
Ongoing
Classification
Class II
Quantity
507 units
Official record key
device-enforcement:Z-3279-2024

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: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648

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.