Micro Therapeutics, Inc.: 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-

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

Details from the source

Reason for recall: 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 Distribution: 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, Colombi Quantity: 18,245 Lot/code info: All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548; PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880; PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808; PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630; PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938; PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108; PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B375523, B410879, B415080, B422400, B438538, B448437, B459694, B460349, B464650, B469525, B474550, B556978, B601007, B608852, B616050, B622657, B625452, B625453, B629552, B683800, B689019, B691414, B698756, B714840, B715051, B721683, B745065, B753732, B763635, B763642, B802419; PED3-027-400-16/00847536030886, 00847536035386, 00847536036703/B326193, B330879, B330881, B357080, B401867, B402034, B403012, B417737, B419736, B420127, B422990, B423257, B426548, B438677, B439156, B439301, B445198, B449040, B449

UPC codes

00847536035263, 00847536030770, 00847536035287, 00847536030787, 00847536035294, 00847536030794, 00847536035317, 00847536030817, 00847536035324, 00847536030824, 00847536030862, 00847536035362, 00847536036680, 00847536030879, 00847536035379, 00847536036697, 00847536030886, 00847536035386, 00847536036703, 00847536036710, 00847536030909, 00847536035409, 00847536036727, 00847536030916, 00847536035416, 00847536036734, 00847536030923, 00847536035423, 00847536036741, 00847536030961, 00847536035461, 00847536036789, 00847536030978, 00847536035478, 00847536036796, 00847536030985, 00847536035485, 00847536036802, 00847536036819, 00847536031005

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.