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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MICROVENTION INC.: ERIC Retrieval Devices Recalled for Incorrect Expiration Dates

Agency Publication Date: September 17, 2024
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Summary

MicroVention Inc. is recalling 1,370 ERIC Retrieval Devices because the product labels incorrectly state a 5-year expiration date instead of the correct 3-year limit. These mechanical devices are used by medical professionals to remove blood clots in patients suffering from acute ischemic strokes. Using the device beyond its true 3-year expiration date may result in the tool failing to perform as intended during critical surgery.

Risk

The incorrect labeling extends the perceived shelf life by two years, meaning the device's materials or sterility may degrade before the date shown on the package. If a degraded device is used, it could fail to effectively remove a blood clot or potentially cause injury during a stroke intervention procedure.

What You Should Do

  1. Identify if your facility has the ERIC Retrieval Device models ER173020, ER174030, or ER176044 by checking the product labels for the following UDI-DI codes: 00810170018831, 00810170018848, or 00810170018862.
  2. Cross-check your inventory against the specific lot numbers provided, such as 0000280707, 0000279433, 0000280790, and others listed in the recall notice, to confirm if your units are affected by the labeling error.
  3. Immediately stop using any affected devices that have exceeded their true 3-year expiration date, even if the label indicates they are still valid.
  4. Contact your healthcare provider or MicroVention Inc. at their Aliso Viejo, California headquarters for specific instructions on returning or relabeling affected inventory.
  5. For further information or to report concerns, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Inventory management and provider notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ERIC Retrieval Device (Model ER173020)
Model / REF:
ER173020
ER173020-US
UDI-DI: 00810170018831
Lot 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
Product: ERIC Retrieval Device (Model ER174030)
Model / REF:
ER174030
ER174030-US
UDI-DI: 00810170018848
Lot 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
Product: ERIC Retrieval Device (Model ER176044)
Model / REF:
ER176044
ER176044-US
UDI-DI: 00810170018862
Lot 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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95151
Status: Active
Manufacturer: MICROVENTION INC.
Sold By: MicroVention Inc.
Manufactured In: United States
Units Affected: 1,370 devices
Distributed To: Arkansas, California, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.