FDA-Device2024-09-25Class II
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.
MICROVENTION INC.
Hazard
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Sold states
U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA.
Affected count
1,370 devices
Manufactured in
35 Enterprise, Aliso Viejo, CA, United States
Products
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3157-2024Don't want to check this manually?
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