Recall Z-0216-2022— Cordis Corporation

Name: FDA recall Z-0216-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-01

Class II · Ongoing

Class II FDA medical device recall by Cordis Corporation, initiated 2021-10-01. It names one FDA 510(k) clearance: K121125. Product: SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.. Reason: There is a potential for distal tip dislodgement or separation..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-10-01
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121125 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·cleared 2012-07-06

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

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Reason for recall

There is a potential for distal tip dislodgement or separation.

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