Device recall: ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device…

Class II FDA enforcement event 95151. Recall start date: 5 Aug 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

MICROVENTION INC. started this device recall on 5 Aug 2024. The firm address in the FDA record is in Aliso Viejo, CA. FDA put the recall in Class II. FDA event 95151 has 1 product record. The first FDA enforcement report date is 25 Sep 2024. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.

Recalling firm

MICROVENTION INC., Aliso Viejo, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 95151: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-3157-2024	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.	1,370 devices	Class II	Ongoing	25 Sep 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of MICROVENTION INC.
Initiated	Product (first record)	Type	Class	Records
30 Apr 2026	BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating	Device	Class II	1
6 Apr 2026	LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m	Device	Class II	1
5 Sep 2025	Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551	Device	Class II	1
29 May 2025	LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400	Device	Class II	1
11 Dec 2024	MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297	Device	Class II	1
2 Dec 2024	Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On	Device	Class II	1
21 Dec 2023	TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600	Device	Class II	1
24 Aug 2023	AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324	Device	Class II	1
7 Jun 2023	FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352	Device	Class II	1
21 Sep 2022	WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.	Device	Class II	1

MICROVENTION INC.: all 16 events

Official channels

FDA enforcement report Z-3157-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 95151. https://recallregister.com/fda/ii/95151/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.
What quantity of product is in FDA event 95151?: The FDA record gives this quantity: 1,370 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.