Trevo Pro 4 Stent Retriever — Class II medical device recall Z-0528-2015
Terminated recall by Concentric Medical Inc, reported 2014-12-17, distributed in AL, CA, IN, NJ, PA. Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned
| Recall number | Z-0528-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Concentric Medical Inc, Mountain View, CA, United States |
| Recall initiated | 2013-11-13 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2014-12-08 |
| Distributed | AL, CA, IN, NJ, PA |
| Quantity | 10 units |
| Lot numbers | 36432, 36757, 36761, 36774 |
| Model numbers | 80021 |
Product
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Reason for recall
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
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-0528-2015. 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.