Lower risk Medical device recall · FDA · Published September 5, 2025

Microvention Flow Re-Direction Devices: Risk of Incomplete Deployment

Microvention recalls specific flow re-direction endoluminal devices due to potential incomplete deployment, which could lead to long-term health issues. Affected models include FRED 27 and related references.

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

🇺🇸 FDA recall #Z-0108-2026Medical device Microvention ›

Lower-risk recall

Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Microvention is recalling certain flow re-direction endoluminal devices that may not deploy correctly, potentially causing long-term health problems. Patients using these devices should contact the company for guidance. Read more at govinfonow.com/recall/51439-microvention-flow-re-direction-devices-risk-of-incomplete-deployment.

Source Summary by GovInfoNow · govinfonow.com/recall/51439-microvention-flow-re-direction-devices-risk-of-incomplete-deployment · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0108-2026

Cite this page

“Microvention Flow Re-Direction Devices: Risk of Incomplete Deployment.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51439-microvention-flow-re-direction-devices-risk-of-incomplete-deployment. Based on FDA recall #Z-0108-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2026%22&limit=1).

The FDA announced on Sept. 5, 2025, that Microvention Inc. is recalling Flow Re-Direction Endoluminal Devices due to potential manufacturing issues with tantalum length and attachment patterns. The agency issued recall number Z-0108-2026 for the voluntary Class II recall affecting 467 units distributed worldwide.

How to tell if you have it

Brand: Microvention
Product: Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508
Product: FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE
Product: FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA
Product: MV-F352427X
Lot codes include REF/UDI-DI(Lot) codes such as FRED5019/00811425020388(0000235839), 00842429117163(0000544498) and others listed in the record
Quantity: 467 units

The hazard

According to the FDA, the flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern. This defect may lead the device to be incompletely open or not properly apposed to the vessel wall, necessitating device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

Context

GovInfoNow's records show Microvention Inc. has 15 other recalls on record since Aug. 7, 2017. Recent Microvention recalls include the Bobby Balloon Guide Catheter Recall on April 30, 2026, due to balloon pinhole defects, and the LVIS Stent Device Recall on April 6, 2026, for risk of vessel injury from manufacturing errors. Other recent recalls of similar products include the Micro Therapeutics Pipeline Flex Embolization Device recall (June 8, 2026) and the CleverCut Single Use Sphincterotome V Recall (Jan. 7, 2026).

How to tell if you have this one

Check for the product model numbers listed in the recall, such as FRED 27, FRED5019, FRED5029, FRED4528, and other references provided in the recall notice. These devices were used in specific medical procedures.

Brand
Microvention
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Microvention
Reach out to Microvention directly to confirm if your device is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, KR, SK, MX, DK, IR, SA, BY, PA, VN, ZA, BR, TW, CN, BE, FR, VE,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Nebraska, New York, South Carolina, South Dakota, Texas.

Recall timeline

FDA published this recall 47 days after the firm started it.

Sep 5, 2025Firm started the recall
Oct 10, 2025FDA classified it Class II
Oct 22, 2025Published 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/51439-microvention-flow-re-direction-devices-risk-of-incomplete-deployment">Microvention Flow Re-Direction Devices: Risk of Incomplete Deployment (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-0108-2026 (September 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0108-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.