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.
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
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.
The device may be manufactured with an incorrect inner stent length, which could cause it to not perform as intended. This might lead to improper treatment of intracranial aneurysms, potentially causing medical complications.
Patients who have received the recalled FRED Flow Re-Direction Endoluminal Devices between June 1, 2020, and September 29, 2020. Medical professionals using these devices for intracranial aneurysm treatment are most at risk.
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.
Review the product model and reference numbers to confirm if your device is in the recall list.
Microvention is recalling certain FRED Flow Re-Direction Endoluminal Devices manufactured between June 1, 2020, and September 29, 2020, due to potential incorrect inner stent length causing improper function.
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.
The recall notice does not specify a remedy or action for affected devices. Contact Microvention directly for guidance.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-2238-2023 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-2238-2023 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.
