Recall Z-2557-2014— Cordis Corporation

Name: FDA recall Z-2557-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-23

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2014-06-23, terminated 2016-12-14. It names one FDA 510(k) clearance: K110133. Product: Cordis EMPIRA RX PTCA Dilatation Catheter. Reason: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Terminated: 2016-12-14
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

Reason for recall

The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

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