Cordis EMPIRA RX PTCA Dilatation Catheter — Class II medical device recall Z-2557-2014
Terminated recall by Cordis Corporation, reported 2014-09-03, distributed in AR, AZ, CA, CO, CT, DC, FL, GA…. The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in t
| Recall number | Z-2557-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2014-06-23 |
| Classified | 2014-08-28 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2016-12-14 |
| Distributed | AR, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY |
| Countries outside the US | AR, BR, CA, CL, CO, MX, PA, VE |
| Quantity | 250,000 units |
| Reason classes | packaging |
| Model numbers | 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S, 85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S and 45 more |
Product
Cordis EMPIRA RX PTCA Dilatation Catheter
Reason for recall
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
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-2557-2014. 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.