Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For… — Class II medical device recall Z-1784-2014
Terminated recall by Cordis Corporation, reported 2014-06-18, distributed in AZ, FL, IL, LA, MA, NJ, OR, SC…. Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
| Recall number | Z-1784-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2013-02-05 |
| Classified | 2014-06-11 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2014-06-23 |
| Distributed | AZ, FL, IL, LA, MA, NJ, OR, SC, TX |
| Countries outside the US | AE, AT, BE, CH, CO, CZ, ES, FR, HU, IL, IN, IR, IT, KW, LB, LU, LV, MA, MX, PL, PT, RU, SA, ZA |
| Quantity | 80 units |
| Lot numbers | 2014-08, CE0001447 |
| Model numbers | 85R30300S |
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reason for recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
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-1784-2014. 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.