FDA-Device2014-12-17Class II
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.
Concentric Medical Inc
Hazard
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Sold states
US Distribution to states of: CA, IN, PA, AL, and NJ.
Affected count
10 units
Manufactured in
301 E Evelyn Ave, N/A, Mountain View, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0528-2015Don't want to check this manually?
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