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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis EMPIRA RX PTCA Dilatation Catheter

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 Class 2 Recall
Cordis EMPIRA RX PTCA Dilatation Catheter
see related information
Date Posted June 11, 2014
Recall Status1 Terminated on June 23, 2014
Recall Number Z-1784-2014
Recall Event ID 64273
Premarket Notification
510(K) Number
K110133 
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
Product Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Code Information Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes, Florida 33014-2802
Manufacturer Reason
for Recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 in Commerce 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, Switzerland, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LOX and Original Applicant = CREGANNA-TACTX MEDICAL
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