FDA-Device2025-03-12Class I
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25,
Micro Therapeutics, Inc.
Hazard
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
Sold states
Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam
Affected count
18,245
Manufactured in
9775 Toledo Way, Irvine, CA, United States
Products
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2025Don't want to check this manually?
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