Micro Therapeutics recalls Pipeline Vantage Embolization Devices with Shield Technology (REFs PED3-027-350-12 to PED3-027-600-50) due to potential incomplete wall apposition and braid deformation in devices ≥4mm, which may lead to thrombosis or serious events. Higher risk in women ≤45 years.
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Micro Therapeutics is recalling certain Pipeline Vantage Embolization Devices with Shield Technology because they may cause incomplete wall apposition and braid deformation (fish-mouthing) when used with diameters of 4mm or larger. This can lead to thrombosis or serious complications, especially in women aged 45 or younger.
The device may not adhere properly to blood vessel walls when used with diameters of 4mm or larger, causing braid deformation (fish-mouthing). This can lead to blood clots or serious complications, particularly in women under 45 years old.
Patients who have received the recalled devices during medical procedures are affected. Women aged 45 or younger are at higher risk for complications.
Check for the product reference codes listed in the recall (e.g., PED3-027-350-12 to PED3-027-600-50) on the device or packaging. All unused devices are included in this recall.
Look for the product reference codes (e.g., PED3-027-350-12 to PED3-027-600-50) on the device or packaging to confirm if it's recalled.
The device may cause incomplete wall apposition and braid deformation (fish-mouthing) in procedures with diameters ≥4mm, potentially leading to thrombosis or serious complications, especially in women ≤45 years.
The recall applies to all unused devices. If you have the recalled reference codes, contact Micro Therapeutics for further instructions.
Yes, the device may cause thrombosis or serious complications, particularly in women aged 45 or younger.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1245-2025 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-1245-2025 from Micro Therapeutics. 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.
