FDA recall Z-3157-2024

MICROVENTION INC. · Class II · device

Product

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-08-05
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3157-2024