FDA-Device2014-09-17Class II
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Concentric Medical Inc
Hazard
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
Sold states
US Distribution including the states of PA, CA, TX, NM, and OH.
Affected count
9 devices
Manufactured in
301 E Evelyn Ave, N/A, Mountain View, CA, United States
Products
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2598-2014Don't want to check this manually?
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