Recall Z-1784-2014 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cordis Corporation
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
| Date | Jun 11, 2014 (initiated Feb 5, 2013) |
| Status | Terminated |
| Reason | Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. |
| Root cause | Process design |
| Action | An Urgent Medical Device Recall letter and Acknowledgement form was sent overnight to mulitple contacts in each account February 7, 2013. A representative will follow-up as necassary to facility obtaining signature, faxing the acknowledgment form to Cordis, collecting and returning units. |
| Quantity | 80 units |
| Distribution | Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerlan |
| 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 |