Z-0003-2014Class II

Cordis ADROIT 6F Guiding Catheter

Name: Z-0003-2014 Cordis ADROIT 6F Guiding Catheter
Creator: Cordis Corporation
Published: 2013-08-12
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2013-08-12 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral... on 2013-08-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0003-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-10-01
Terminated: 2014-09-30
Recalling firm: Cordis US Corp.
Product: Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 1238 units
Distribution: 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
Product codes and lots: Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0003-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0003-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-10-01

Product code DQY

K131225Class IIAdroit Guiding CatheterCordis Corp., A Johnson & Johnson Co. / cleared 2013-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)