Home / Recalls / Cordis Corporation / Z-2556-2014

Z-2556-2014 Class II Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

FDA device recall Z-2556-2014 was initiated by Cordis Corporation on Jun 23, 2014 and is designated Class II. 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 recall status is terminated (terminated Dec 14, 2016). Affected quantity: 250,000 units.

Recall Details

Product Type
Devices
Report Date
Sep 3, 2014
Initiation Date
Jun 23, 2014
Termination Date
Dec 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
250,000 units

Product Description

Cordis EMPIRA NC 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.

Distribution Pattern

Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.

Code Information

63 Catalog numbers: 75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, 75R25400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, and 75R25400N.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2556-2014
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources