Cordis ADROIT 6F Guiding Catheter recallZ-0003-2014 · Cordis Corporation · initiated Aug 12, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cordis Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-0003-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 12, 2013
- Posted by the FDA
- Oct 1, 2013
- Recalling firm
- Cordis Corporation
- Quantity
- 1238 units
- Product code
- DQY
- FDA submissions
- K131225
- 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 description
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
5 devices cleared under K131225 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADROIT 67271700Cordis US Corp. · Catheter, percutaneous3 reports
- ADROIT 67203400Cordis US Corp. · CATHETER, PERCUTANEOUS2 reports
- ADROIT 67208200Cordis US Corp. · CATHETER, PERCUTANEOUS2 reports
- ADROIT 67205400Cordis US Corp. · CATHETER, PERCUTANEOUS1 report
- ADROIT 67227800Cordis US Corp. · CATHETER, PERCUTANEOUS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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