Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Trevo Pro 4 Stent Retriever Recalled by Concentric Medical Inc Due to Product shipped to US customers had non U.S....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Concentric Medical Inc directly.
Affected Products
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.
Quantity: 10 units
Why Was This Recalled?
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Where Was This Sold?
This product was distributed to 5 states: AL, CA, IN, NJ, PA
About Concentric Medical Inc
Concentric Medical Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report