The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.

Recall details

Manufacturer

Stryker Neurovascular

Distributor

Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.

Lot

Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995; M00316330/07613252187165/0000142692, 0000158995; M00313010/07613252186922/0000129027, 0000129028, 0000129029, 0000129218, 0000129219, 0000129630, 0000129631, 0000129841, 0000129842, 0000129902, 0000130225, 0000130226, 0000130410, 0000130411, 0000130412, 0000130502, 0000130503, 0000130643, 0000130645, 0000130869, 0000130870, 0000131304, 0000131307, 0000131343, 0000131724, 0000131725, 0000131726, 0000132154, 0000132155, 0000132582, 0000132640, 0000132641, 0000133182, 0000133183, 0000133391, 0000133565, 0000133566, 0000133567, 0000133568, 0000133928, 0000133929, 0000134128, 0000134129, 0000134130, 0000134307, 0000134308, 0000135009, 0000135148, 0000135149, 0000135303, 0000135304, 0000135806, 0000135807, 0000136252, 0000136923, 0000137267, 0000137322, 0000137373, 0000137374, 0000137375, 0000138751, 0000139437, 0000141635, 0000142248, 0000142249, 0000142541, 0000142691, 0000143123, 0000143350, 0000143351, 0000143585, 0000143955, 0000144141, 0000144320, 0000144379, 0000144380, 0000144739, 0000144760, 0000144761, 0000144764, 0000144959, 0000144960, 0000145884, 0000145885, 0000146228, 0000146390, 0000146515, 0000146843, 0000146916, 0000147040, 0000147186, 0000147306, 0000147440, 0000147585, 0000147876, 0000148965, 0000149562, 0000150095, 0000150872, 0000150873, 0000151381, 0000151461, 0000151677, 0000151847, 0000151848, 0000152230, 0000152231, 0000152375, 0000152522, 0000152977, 0000153282, 0000153370, 0000153970, 0000154140, 0000154302, 0000154303, 0000154779, 0000154780, 0000154894, 0000154895, 0000155020, 0000155068, 0000156317, 0000156321, 0000156615, 0000156626, 0000156794, 0000156800, 0000157226, 0000157227, 0000157892, 0000157894, 0000158127, 0000158128, 0000158131, 0000158339, 0000158340, 0000159324, 0000159932, 0000159997, 0000159998, 0000160368, 0000160369, 0000160434, 0000160435, 0000160893, 0000160894, 0000160895, 0000161061, 0000161062, 0000161063, 0000162104, 0000162105, 0000162106, 0000162896, 0000162991, 0000162992, 0000163716, 0000163967, 0000163968, 0000164443, 0000164470, 0000165356, 0000165363, 0000165364, 0000166540, 0000166542, 0000166544, 0000170149, 0000170246, 0000170940, 0000171065, 0000171235, 0000172266, 0000172267, 0000172381, 0000172787, 0000172865, 0000172866, 0000173279, 0000174292, 0000174373, 0000174380, 0000174409, 0000174680, 0000174681, 0000175067, 0000175068, 0000175069, 0000175640, 0000175641, 0000175983, 0000175984, 0000175985, 0000175986, 0000176344, 0000176345, 0000176504, 0000176523, 0000176830, 0000176836, 0000177535, 0000178075, 0000178076, 0000178532, 0000178533, 0000178535, 0000178626, 0000179628, 0000179629, 0000180361, 0000180738, 0000180800, 0000193546; M00313020/07613252186939/0000159372, 0000172593; M00313310/07613252186946/0000135007, 0000135008, 0000136409, 0000136410,0000136679, 0000139937, 0000139938, 0000140307, 0000140689, 0000140690, 0000141634, 0000141833, 0000142246, 0000152799, 0000153160, 0000153453, 0000153968, 0000153969, 0000154301, 0000157222, 0000157223, 0000157224, 0000159320, 0000159370, 0000160740, 0000172380, 0000172594, 0000172619, 0000172661, 0000172662, 0000172748, 0000172786, 0000176476, 0000176840, 0000176841, 0000177540, 0000178232, 0000180657, 0000180737, 0000180795; M00313410/07613252186960/0000173997

Risk classification

Class II

Area (FDA)

device

Country

United States