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ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mecha...

FDA Device Recall #Z-3157-2024 — Class II — August 5, 2024

Recall Summary

Recall Number Z-3157-2024
Classification Class II — Moderate risk
Date Initiated August 5, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MICROVENTION INC.
Location Aliso Viejo, CA
Product Type Devices
Quantity 1,370 devices

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.

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 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.

Lot / Code Information

Model Number: ER173020-US UDI-DI code: 00810170018831 Lot/Batch Numbers: 0000280707 0000281277 0000282616 0000337055 0000339787 0000341352 0000346638 0000347204 0000347518 0000369548 0000373878 0000383975 0000388574 0000390920 0000408227 0000413356 0000483914 0000509754 0000552788 0000556936 0000565975 0000584166 0000595486 0000605157 0000610234 0000616881 0000644624 0000648880 0000650593 Model Number: ER174030-US UDI-DI code: 00810170018848 Lot/Batch Numbers: 0000279433 0000281276 0000281278 0000282116 0000283271 0000337041 0000338960 0000342289 0000345185 0000345946 000034154 0000347296 0000364249 0000367420 0000372400 0000375208 0000385910 0000391720 0000394172 0000399765 0000402617 0000406053 0000412461 0000468600 0000472204 0000479549 0000488883 0000548672 0000554916 0000561944 0000563812 0000578999 0000584167 0000588191 0000599947 0000602913 0000619853 0000622476 0000630060 0000655111 Model Number: ER176044-US UDI-DI code: 00810170018862 Lot/Batch Numbers: 0000280790 0000181279 0000281275 0000336496 0000337865 0000340323 0000342830 0000347509 0000354010 0000354790 0000355704 0000361497 0000368172 0000374160 0000387557 0000389821 0000394759 0000401148 0000405396 0000409331 0000466714 0000470240 0000478434 0000481899 0000503647 0000504822 0000556934 0000558955 0000558957 0000563811 0000575805 0000578998 0000582277 0000592294 0000605158 0000619854 0000626526 0000651121

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Z-2188-2025 Class II LIFEPEARL Drug Elutable Microspheres: 200 +/- 5... May 29, 2025
Z-1121-2025 Class II MicoVention Terumo, LVIS Intraluminal Support D... Dec 11, 2024
Z-0990-2025 Class II Microvention, Headway" 17 Advanced Straight Mic... Dec 2, 2024
Z-0868-2024 Class II TERUMO HydroPearl Compressible Microspheres for... Dec 21, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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