FDA Device recall Z-0528-2015
Trevo Pro 4 Stent Retriever, Model number 80021
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Trevo Pro 4 Stent Retriever, Model number 80021 by Concentric Medical, citing product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0528-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-13 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Concentric Medical |
| Distribution | AL, CA, IN, NJ, PA |
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
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Identifiers
| code_info | Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015 |
|---|
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-0528-2015%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.