Recall Z-1507-2013— Cordis Corporation

Name: FDA recall Z-1507-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-23

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2013-04-23, terminated 2014-06-27. It names one FDA 510(k) clearance: K081996. Product: 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.. Reason: Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-04-23
Terminated: 2014-06-27
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K081996 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·cleared 2009-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.