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.
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.
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.
The devices may have manufacturing issues with tantalum length or attachment patterns, causing them to not open fully or stay properly positioned against the vessel wall. This could lead to the need for device removal and potential long-term health consequences.
Patients who have received the recalled flow re-direction devices (FRED 27 models) are most at risk. The recall applies to individuals who have undergone procedures using these specific devices.
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.
Reach out to Microvention directly to confirm if your device is affected and get instructions for next steps.
The recall indicates a potential risk of incomplete deployment, so affected devices should not be used without contacting Microvention first.
Contact Microvention to determine if your device is affected and follow their instructions for next steps.
Look for the model numbers listed in the recall, such as FRED 27, FRED5019, FRED5029, FRED4528, and other references provided in the notice.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-0108-2026 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-0108-2026 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
