CLASS II Device recall · Reported 9 Oct 2013 · FDA Enforcement Report
Adroit 6F Guiding Catheter recalled by Cordis
Cordis is recalling Adroit 6F Guiding Catheter, distributed nationwide in the US. The recall was initiated on 12 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0003-2014
- FDA event ID
- 66026
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Aug 2013
- FDA classified
- 1 Oct 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 12 Aug 2013 | Recall initiated by company | |
| 1 Oct 2013 | Classified by FDA | +50 days |
| 9 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Where it was distributed
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
Nationwide ArizonaCaliforniaFloridaIdahoLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew HampshireNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTexasVirginiaWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cordis
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
| Device | CLASS II | Smart Flex Bil The S.M.A.R.T.¿ Flex Biliary Stent System recalled | Cordis | Other | 7 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |