Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EV3 Pipeline Flex Embolization Device with Flex Shield Technology Recalled by Micro Therapeutics Inc, Due to Due to potential push wire fractures in the...
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
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Quantity: 16,169 total devices for all model/products
Why Was This Recalled?
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Where Was This Sold?
This product was distributed to 48 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
About Micro Therapeutics Inc,
Micro Therapeutics Inc, has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report