FDA recall Z-3293-2024

Boston Scientific Corporation · Class II · device

Product

AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) 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): M00517790

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2024-08-01
Report date: 2024-10-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3293-2024