The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. 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.
Publicado el 12 de junio de 2024 · Inicio del retiro: 18 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Neurovascular
- Distribuidor
- 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.
- Lote
- Catalog/UDI-DI/Lots: M00326110/04546540688736/0000064108, 0000065017, 0000065616, 0000066470, 0000066581, 0000067561, 0000067801, 0000068246, 0000069276, 0000071094, 0000071841, 0000073548, 0000075207, 0000077751, 0000078371, 0000078837, 0000080548, 0000080988, 0000082965, 0000083195, 0000086130, 0000088254, 0000092394, 0000092395, 0000092396, 0000095029, 0000097492, 0000098543, 0000104203, 0000111901, 0000122898, 0000123072, 0000123529, 0000126054, 0000126497, 0000126852, 0000134099, 0000135605, 0000135804, 0000144373, 0000145738, 0000145739, 0000146146, 0000146147, 0000150989, 0000153606, 0000162889, 0000162890, 0000162891, 0000172273, 0000174770, 0000175634, 0000175636, 0000175637; M00326320/04546540688750/0000105764, 0000109900, 0000181399; M00326010/04546540688729/0000063878, 0000063985, 0000064269, 0000064281, 0000064309, 0000064357, 0000064360, 0000064370, 0000064796, 0000065004, 0000065161, 0000065227, 0000065269, 0000065449, 0000065450, 0000065733, 0000065760, 0000065781, 0000065819, 0000065891, 0000066007, 0000066076, 0000066129, 0000066311, 0000066337, 0000066383, 0000066490, 0000066583, 0000066931, 0000066988, 0000067168, 0000067331, 0000067453, 0000067466, 0000067566, 0000067655, 0000067710, 0000067762, 0000067898, 0000068187, 0000068245, 0000068428, 0000068556, 0000069385, 0000069506, 0000069549, 0000069573, 0000069755, 0000069788, 0000069918, 0000070038, 0000070039, 0000070422, 0000070863, 0000071213, 0000071374, 0000071375, 0000071839, 0000071840, 0000073408, 0000073409, 0000073514, 0000073888, 0000074665, 0000074666, 0000074951, 0000074952, 0000075877, 0000076063, 0000076064, 0000076161, 0000076162, 0000076379, 0000076454, 0000077608, 0000077609, 0000077610, 0000078110, 0000078111, 0000078271, 0000078369, 0000078877, 0000078902, 0000080915, 0000080987, 0000081397, 0000081454, 0000081670, 0000082734, 0000082735, 0000084656, 0000084657, 0000084861, 0000084864, 0000085365, 0000085953, 0000086129, 0000086175, 0000086200, 0000086337, 0000087870, 0000087871, 0000087872, 0000088367, 0000088651, 0000088652, 0000090311, 0000091480, 0000091715, 0000092004, 0000092839, 0000093332, 0000093534, 0000094776, 0000094818, 0000095080, 0000095172, 0000096911, 0000096912, 0000097447, 0000097951, 0000098059, 0000099701, 0000099702, 0000099953, 0000100863, 0000100925, 0000100986, 0000102835, 0000102934, 0000103038, 0000103039, 0000104204, 0000104522, 0000104523, 0000106631, 0000106632, 0000106718, 0000107496, 0000107498, 0000108264, 0000108487, 0000109375, 0000109781, 0000109782, 0000109899, 0000111454, 0000111900, 0000112880, 0000112881, 0000113135, 0000113476, 0000113477, 0000113681, 0000114843, 0000114844, 0000114845, 0000115168, 0000116702, 0000116703, 0000117042, 0000117043, 0000121693, 0000121695, 0000122112, 0000122257, 0000122470, 0000123530, 0000123902, 0000123982, 0000123984, 0000125041, 0000125147, 0000125714, 0000125715, 0000126047, 0000126048, 0000126049, 0000126496, 0000128252, 0000128618, 0000128619, 0000128620, 0000129206, 0000129207, 0000130642, 0000130824, 0000130864, 0000130865, 0000132955, 0000133180, 0000133181, 0000134097, 0000134098, 0000137241, 0000137242, 0000138582, 0000138583, 0000139438, 0000139439, 0000139440, 0000139441, 0000140683, 0000140685, 0000140686, 0000140687, 0000146927, 0000146928, 0000147307, 0000150096, 0000150097, 0000150879, 0000150880, 0000150988, 0000152801, 0000152802, 0000152978, 0000153316, 0000153369, 0000157899, 0000158129, 0000158130, 0000158341, 0000158800, 0000159841, 0000159842, 0000161219, 0000161220, 0000162107, 0000162894, 0000166350, 0000166351, 0000166352, 0000166353, 0000170244, 0000172271, 0000172272, 0000172302, 0000172304, 0000172599, 0000172600, 0000172620, 0000172621, 0000173240, 0000173242, 0000174284, 0000174287, 0000174768, 0000174769, 0000175639, 0000175710, 0000175750, 0000176474, 0000176475, 0000176833, 0000176834, 0000177999, 0000178005, 0000180681; M00326310/04546540688743/0000065570, 0000067169, 0000068247, 0000079906, 0000090099, 0000094378, 0000100182,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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