—#128815

Product

Cordis EMPIRA NC RX PTCA Dilatation Catheter

FDA product code: LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K110133
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Environmental control

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

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.

Timeline

Recall initiated: 2014-06-23
Posted by FDA: 2014-08-28
Terminated: 2016-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.