FDA Device recall Z-1784-2014
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use
- FDA Device
- Class II
- terminated
- Published 2014-06-18
On 2014-06-18 the FDA classified a Class II recall of Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use by Cordis, citing dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1784-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-05 |
| Published | 2014-06-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cordis |
| Distribution | AZ, FL, IL, LA, MA, NJ, OR, SC, TX |
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reason
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Identifiers
| code_info | Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1784-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.