FDA Device recall Z-1947-2016
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of Cordis PRECISE (R) RX Nitinol Stent System (Biliary) by Cordis, citing inability to deploy the stent or partial stent deployment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1947-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-04 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cordis |
| Distribution | US |
Product
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Reason
Inability to deploy the stent or partial stent deployment.
Identifiers
| code_info | Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07…Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2016%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.