FDA Device recall Z-0879-2015
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only by Ev3, citing two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ev3 |
| Distribution | n/a |
Product
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Reason
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Identifiers
| code_info | Lot # 9922795 |
|---|
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-0879-2015%22
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