Unrated Medical device recall · FDA · Published June 7, 2023

Microvention FRED Flow Re-Direction Device Recall: Incorrect Stent Length Risk

Microvention recalls FRED Flow Re-Direction Endoluminal Devices made between June 1, 2020, and September 29, 2020, due to potential incorrect inner stent length causing improper function.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2238-2023Medical device Microvention ›

Recall notice

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

Take action

Contact the company

Recalling firmMICROVENTION INC.35 Enterprise · Aliso Viejo, CA 92656

✎ GovInfoNow plain-language explainer

Microvention is recalling certain FRED Flow Re-Direction Endoluminal Devices manufactured between June 1, 2020, and September 29, 2020. These devices may have an incorrect inner stent length, which could cause them to not function as intended, potentially leading to medical complications. Read more at govinfonow.com/recall/57880-microvention-fred-flow-re-direction-device-recall-incorrect-stent-length.

Source Summary by GovInfoNow · govinfonow.com/recall/57880-microvention-fred-flow-re-direction-device-recall-incorrect-stent-length · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2238-2023

Cite this page

“Microvention FRED Flow Re-Direction Device Recall: Incorrect Stent Length Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57880-microvention-fred-flow-re-direction-device-recall-incorrect-stent-length. Based on FDA recall #Z-2238-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2238-2023%22&limit=1).

Microvention Inc. recalled FRED Flow Re-Direction Endoluminal Devices manufactured between June 1, 2020, and September 29, 2020, because they may have an incorrect inner stent length that prevents intended performance, the FDA said on June 7, 2023.

How to tell if you have it

Brand: Microvention
Product: FRED Flow Re-Direction Endoluminal Device
REF codes: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA
Lot codes: MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627 and associated UDI/Lot numbers listed in the record
Manufacture dates: June 1, 2020, to September 29, 2020
Units affected: 474

The hazard

The intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended, according to the FDA.

Context

GovInfoNow's records show Microvention Inc. has 15 other recalls on record since August 7, 2017. Other recent recalls of similar products include Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), Microvention LVIS Stent Device Recall (April 6, 2026), and Microvention Flow Re-Direction Devices recall (September 5, 2025).

How to tell if you have this one

Check the product model and reference numbers listed in the recall notice. Devices manufactured between June 1, 2020, and September 29, 2020, with specific reference codes like FRED3507-PMA, FRED3511, and others are affected.

Brand
Microvention
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Review the product model and reference numbers to confirm if your device is in the recall list.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 28 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS and the countries of Taiwan, Chile, India, South Korea,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 56 days after the firm started it.

Jun 7, 2023Firm started the recall
Jul 27, 2023FDA classified it Class II
Aug 2, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57880-microvention-fred-flow-re-direction-device-recall-incorrect-stent-length">Microvention FRED Flow Re-Direction Device Recall: Incorrect Stent Length Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2238-2023 (June 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2238-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.