Z-2557-2014Class II

Cordis EMPIRA RX PTCA Dilatation Catheter

Name: Z-2557-2014 Cordis EMPIRA RX PTCA Dilatation Catheter
Creator: Cordis Corporation
Published: 2014-06-23
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2014-06-23 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis EMPIRA RX PTCA Dilatation Catheter on 2014-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2557-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Posted: 2014-08-28
Terminated: 2016-12-14
Recalling firm: Cordis US Corp.
Product: Cordis EMPIRA RX PTCA Dilatation Catheter
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Cordis Corp sent Urgent Medical Device Correction Letters dated June 23, 2014, to all affected customers. Those in the Foreign Countries were sent via E-mail dated June 23, 2014. The letter identified the product the problem and the action needed to be taken by the customer. Cordis and Creganna-Tactx are not removing the products, but rather providing additional labeling (customer letter) advising the user not to use the product if unusual resistance is felt during removal of the balloon cover. Cordis and Creganna-Tactx explained in the letter to the consignees that is is known that balloons with hydrophilic coating are susceptible to expansion of the coating at extremely elevated humidity, therefore, it is important for the User to follow the current labeling, to store the product in a cool, dark and dry place. Action requested on your part: "Pass on this letter to anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. "Maintain awareness of this communication until the information has been incorporated into the Cordis EMPIRA" NC RX and EMPIRA" RX PTCA dilatation catheter labeling. "Retain this letter with affected product. "Report all balloon cover removal difficulties through the standard complaint process. "For questions related to the issue please contact Cordis Endovascular Medical information Line 877-DEVICE5 (877-338-4235), Monday through Friday from 9:00AM to 5:00 PM EDT. "For questions related to the Acknowledgment Form and its return, please contact Cordis QA at (786) 313-8730.
Quantity in commerce: 250,000 units.
Distribution: 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.
Product codes and lots: 70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2557-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2556-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2557-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28

Product code LOX

K110133Class IIEmpira Rx Ptca Dilatation Catheter, Empria Nc Rx Ptca Dilatation CatheterCreganna-Tactx Medical / cleared 2011-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)