Device product

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

Z-1784-2014

February 05, 2013

Class II

Product summary

Firm: Cordis Corporation
Event: Event 64273
Status: Terminated
Classification: Class II
Quantity: 80 units
Official record key: device-enforcement:Z-1784-2014

Official wording

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

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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