Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1509-2013 — FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.

U.S. FDA — Device Enforcement · United States · 2013-04-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1509-2013
Date of alert
2013-04-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cordis Corporation
Product category
device
Product type
Devices
Reported risk: Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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