MICROVENTION INC.: Device Recall

Recall #Z-3157-2024 · 08/05/2024

Class II: Risk

Recall Details

Recall Number
Z-3157-2024
Classification
Class II
Product Type
Device
Recalling Firm
MICROVENTION INC.
Status
Ongoing
Date Initiated
08/05/2024
Location
Aliso Viejo, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,370 devices

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.

Product Description

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.

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.