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Concentric Medical Inc recalls Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore
Recalled December 17, 2014 · FDA recall Z-0528-2015 · Concentric Medical
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. · FDA Class II
Units
10 units
Sold at
US Distribution to states of: CA, IN, PA, AL, and NJ.
Description
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
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.
Manufacturer(s)
Concentric Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →