Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular… — Class II medical device recall Z-0003-2014
Terminated recall by Cordis Corporation, reported 2013-10-09, distributed nationwide. Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millime
| Recall number | Z-0003-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-10-01 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, GR, HU, IL, IT, LV, NL, PL, PT, SE, SI |
| Quantity | 1,238 units |
| Reason classes | labeling |
| Lot numbers | 15885645, 15887472, 15887473, 15887474, 15892736, 15892737, 15892738, 15892739, 15892740, 15892741, 15897416, 15897418, 15897420, 15897422, 15897424, 15901314, 15901319, 15901321, 15901323, 15916942, 15916943, 15918614, 15922021, 15925687, 67200000, 67200200, 67200400, 67200500, 67203400, 67203600, 67204000, 67205200, 67205400, 67205600, 67206000, 67207200, 67208000, 67208200, 67208300, 67212600 and 2 more |
| Model numbers | 15885645, 15887472, 15887473, 15887474, 15892736, 15892737, 15892738, 15892739, 15892740, 15892741, 15897416, 15897418, 15897420, 15897422, 15897424, 15901314, 15901319, 15901321, 15901323, 15916942, 15916943, 15918614, 15922021, 15925687, 67200000 and 17 more |
Product
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0003-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.