Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic Pipeline Vantage Embolization Device with Shield Technology Recalled by Micro Therapeutics, Inc. Due to Use of embolization device with diameters greater-than-or-equal-to 4mm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Micro Therapeutics, Inc. directly.
Affected Products
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
Quantity: 7820
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Micro Therapeutics, Inc.
Micro Therapeutics, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report