Recall Z-2557-2014 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cordis Corporation
Cordis EMPIRA RX PTCA Dilatation Catheter
| Date | Aug 28, 2014 (initiated Jun 23, 2014) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110133 | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER Creganna-Tactx Medical, Jun 10, 2011 |