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Recall Observatory FDA recall evidence

Device product

WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW 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): M00516720

Z-3277-2024

August 01, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95124
Status
Ongoing
Classification
Class II
Quantity
79 units
Official record key
device-enforcement:Z-3277-2024

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: 08714729778059 Lot Numbers: 32770266, 32780362, 32865975, 32906417, 32975732, 33017656, 33128876, 33167135

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.