Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
FDA Recall Z-1784-2014 · Posted 2014-06-11
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeLOX
Date Initiated2013-02-05
Date Terminated2014-06-23
Product Quantity80 units
Reason for Recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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