Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
FDA Recall Z-0003-2014 · Posted 2013-10-01
Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2013-08-12
Date Terminated2014-09-30
Product Quantity1238 units
Reason for Recall
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Firm Action
Cordis sent an Urgent Medical Device Recall letter dated August 12, 2013 Acknowledgement Form to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected product in a manner that ensures the product will not be used. Customers were asked to review, complete, sign and return the enclosed Acknowledgement form directly to Cordis to the fax number on the form. For questions call the Customer Service number at 800-561-7683.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
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.