Recalls / —

—#115742

Product

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

FDA product code

LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K110133

Affected lot / code info

Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08

Why it was recalled

Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm

Cordis Corporation

Address

14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern

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, Switzerland, and United Arab Emirates.

Timeline

Recall initiated

2013-02-05

Posted by FDA

2014-06-11

Terminated

2014-06-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #115742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.