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Cordis Corporation recalls Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Recalled June 18, 2014 · FDA recall Z-1784-2014 · Cordis
Hazard
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. · FDA Class II
Units
80 units
Sold at
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.
Description
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →