Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK
Check against the official notice below — it lists the full affected range.
Stryker Neurovascular is recalling certain Trevo XP ProVue Retriever stent retrievers and associated procedure packs due to an increase in fractures of the flexible, tapered core wire. When the core wire fractures, the stent retriever can separate from the wire and remain inside the blood vessels during medical procedures. The recall affects 5,365 units distributed across the United States, numerous international locations, and involves specific product reference numbers and lot codes for various sizes and configurations of the device.
The affected products were distributed to multiple states including Pennsylvania, Ohio, Alaska, New York, Virginia, Illinois, California, and many others, as well as to countries including New Zealand, Argentina, Australia, Mexico, South Korea, Brazil, Germany, Spain, France, Belgium, Netherlands, and others. The source document does not specify a remedy for consumers or healthcare providers who have these products.
Written by software from the official notice below. Not reviewed by a lawyer.
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
Reason for recall: Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature. Distribution: U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Estonia, Lithuania, Slovenia, Australia, Finland, Luxembourg, South Africa, Austria, France, Mexico, South Korea, Belgium, Germany, Netherlands, Spain, Brazil, Greece, N Quantity: 5365 Lot/code info: REF/Lots: 90182/ 0000030024, 0000030025, 0000030026, 0000030251, 0000030252, 0000030253, 0000030408, 0000030409, 0000030410, 0000030921, 0000030922, 0000030931, 0000031336, 0000031585, 0000031761, 0000031762, 0000031763, 0000032042, 0000032043, 0000032309, 0000032310, 0000032400, 0000032401, 0000032402, 0000032403, 30024, 30251, 30922, 31336, 31761, 31762; 90185/ 0000030030, 0000030031, 0000030260, 0000030261, 0000030407, 0000030415, 0000030416, 0000030924, 0000030925, 0000030926, 0000031338, 0000031588, 0000031764, 0000031765, 0000032040, 0000032041, 0000032313; 90186/ 0000030032, 0000030262, 0000030406, 0000030417, 0000030418, 0000030419, 0000030927, 0000030928, 0000030929, 0000030930, 0000031339, 0000031340, 0000031341, 0000031587, 0000032046, 0000032047; M0032PK42010002/ 38166585, 38191261, 38191264, 38449970, 38636576; M0032PK43010002/ 36967533, 36967572, 36967573, 36967574, 36967575, 36967576, 36967577, 36967578, 36967579, 36967580; 93067/ 60200184892, 60200184893, 60200185332, 60200186591, 60200186592, 60200187741, 60200187742, 36836835, 36836838, 36891540, 36912340, 36912354, 36967536, 36984339, 36984362, 36984363, 36984364, 36984365, 36984366, 37003135, 37003141, 37003144, 37049334, 37049335, 37049336, 37049345, 37056132, 37077332, 37089641, 37108537, 37108540, 37125434, 37125468, 37158939, 37158940, 37174352, 37195439, 37195440, 37195441, 37195442, 37195444, 37195448, 37228358, 37228360, 37329459, 37495860, 37510394, 36448781, 36461581, 36461583, 36498382, 36498384,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.