Recall Z-1784-2014— Cordis Corporation

Name: FDA recall Z-1784-2014
Creator: U.S. Food and Drug Administration
Published: 2013-02-05

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2013-02-05, terminated 2014-06-23. It names one FDA 510(k) clearance: K110133. Product: Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.. Reason: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Terminated: 2014-06-23
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K110133 — EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETERCreganna-Tactx Medical·cleared 2011-06-10

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

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

Reason for recall

Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

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