CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report

ERIC Retrieval Device recalled by Microvention

Microvention is recalling ERIC Retrieval Device, distributed nationwide in the US. The recall was initiated on 5 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled1,370 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3157-2024
FDA event ID: 95151
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Aug 2024
FDA classified: 17 Sep 2024
Reported: 25 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Aug 2024	Recall initiated by company
17 Sep 2024	Classified by FDA	+43 days
25 Sep 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Florida Indiana Louisiana Massachusetts Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania South Carolina Texas Virginia

Questions about this recall

Is ERIC Retrieval Device recalled?

Yes. Microvention recalled ERIC Retrieval Device on 5 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3157-2024.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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 should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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