ev3 Protege Rx Tapered Carotid Stent System — Class II medical device recall Z-0878-2015
Terminated recall by Ev3, Inc., reported 2015-01-07. Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEP
| Recall number | Z-0878-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ev3, Inc., Plymouth, MN, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2014-12-29 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2015-07-17 |
| Countries outside the US | DE, ES, FR, GB, IT, JP, PL, RO, RU, TR |
| Quantity | 14 |
| Reason classes | labeling |
| Lot numbers | 9922452 |
Product
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, 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 for recall
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.
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-0878-2015. 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.