Class 1 Device Recall Trevo XP ProVue Retriever

• Date Initiated by Firm: September 21, 2020
• Date Posted: October 21, 2020
• Recall Status: Terminated on April 01, 2024
• Recall Number: Z-0114-2021
• Recall Event ID: 86583
• 510(K)Number: K190779
• Product Classification: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment - Product Code POL
• Product: 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, M0033PK62523002
• Code Information: 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, 36498680, 36498681, 36498682, 36529509, 36529545, 36529546, 36529547, 36529548, 36529549, 36529550, 36529551, 36529552, 36529553, 36529554, 36529555, 36529556, 36547189, 36547195, 36547197, 36547215, 36632788, 36632794, 36652186, 36691283, 36714887, 36735085, 36735086, 36735087, 36735088, 36735089, 36753486, 36753488, 36753497, 36799849, 36799850, 36799851, 36799859, 36799860, 36836842, 36836843, 36857851, 36857852, 36857853, 36857854, 36857855, 36857856, 36875438, 36875442, 36875443, 36875444, 36875453, 36912333, 36912353, 36930560, 36930561, 36930565, 36930569, 36930579, 36947233, 36947255, 36947256, 36947257, 36947258, 36967551, 36984352, 36984354, 36984355, 37003140, 37011643, 37032438, 37049357, 37108533, 37108544, 37108546, 37108547, 37108549, 37108550, 37108551, 37108565, 37108566, 37108567, 37108568, 37108569, 37108570, 37108571, 37108572, 37108573, 37125435, 37125448, 37125449, 37125456, 37125457, 37125458, 37141942, 37158947; 93068/ 60200189251, 60200189252, 60200189253, 60200190221, 60200190222, 60200190223, 60200190224, 60200191041, 60200191042, 60200191043, 60200191044, 37032432, 37032434, 37032435, 37077333, 37108538, 37141980, 37195438, 37212242, 37228359, 37263852, 37281945, 37313953, 37345011, 37345012, 37345013, 37384855, 37424965, 37479670, 37479734, 37510391, 37510392, 37539290, 37539291, 37539301, 37610409, 37659707, 37676912, 37693604, 37693635, 37713603, 37713604, 37754601, 37795612, 37814519, 37814520, 37814521, 37814522, 37849537, 37849538, 37849539, 37863831, 37969756, 37969757, 37969758, 37984459, 37984460, 37984468, 38013747, 38013948, 38013951, 38013952, 38013962, 38028310, 38045557, 38045558, 38045566, 38045567, 38045570, 37049353, 37049354, 37065739, 37077336, 37108545, 37108548, 37125460, 37125461, 37125467, 37158943, 37195443, 37212245, 37228338, 37228344, 37228345, 37228346, 37228357, 37228361, 37244247, 37244252, 37244253, 37263862, 37263875, 37297752, 37313955, 37329458, 37329460, 37329464, 37329465, 37344990, 37344996, 37364784, 37364785, 37364786, 37364787, 37384864, 37402863, 37402864, 37479669, 37479711, 37479714, 37479715, 37479752, 37480074, 37480075, 37480076, 37480078, 37480081, 37480084, 37480086, 37480089, 37480090, 37480091, 37480092, 37480093, 37480094, 37480095, 37495864, 37495867, 37495868, 37543891, 37543895, 37575302, 37575304, 37575315, 37575317, 37610402, 37628108, 37628109, 37644715, 37676901, 37676904, 37676905, 37676909, 37693620, 37693621, 37693622, 37693623, 37693624, 37693625, 37693630, 37693634, 37713620, 37733704, 37733712, 37733716, 37754602, 37754607, 37754608, 37754615, 37754616, 37754617, 37754618, 37754621, 37777326, 37777327, 37777335, 37795619, 37795620, 37795621, 37795622, 37814544, 37814545, 37833331, 37833332, 37849512, 37849513, 37849517, 37849518, 37849520, 37849521, 37849525, 37849526, 37849527, 37849543, 37849552, 37850811, 37850812, 37863830, 37863838, 37863842, 37863850, 37882547, 37882548, 37882554, 37919235, 37923331, 37954149, 37969749, 37969775, 37969776, 37969777, 37969778, 37984471, 38000241; M0032PK62510002/ 36967569, 37011639, 37882543, 37938251; M0033PK42022002/ 38146882, 38146883, 38166603, 38166604, 38174955, 38174975, 38185258, 38185259, 38185260, 38185263, 38185267, 38195456, 38281762, 38391766, 38391767, 38391769, 38391770, 38391771, 38391772, 38392064, 38392960, 38395862, 38476062, 38476065, 38476066, 38476067, 38516767, 38599024, 38166612, 38229563, 38261557, 38311966, 38392961, 38395871, 38408188, 38453760, 38453765, 38492462, 38572772, 38586764, 38636571, 38649867; M0033PK43022002/ 36431078, 36431081, 36431082, 36448779, 36448780, 36498687, 36498688, 36498689, 36498690, 36498691, 36514194, 36529540, 36529541, 36547182, 36547187, 36547204, 36614192, 36632790, 36632797, 36672623, 36714883, 36714884, 36714886, 36735105, 36735106, 36753494, 36753495, 36753496, 36769792, 36769793, 36787186, 36787189, 36799835, 36799840, 36836844, 36836845, 36875448, 36875449, 36875450, 36875451, 36912346, 36912351, 36912352, 36984348, 36984349, 36984350, 36984351, 36984353, 37011640, 37032440, 37049350, 37049355, 37077337, 37077339, 37125462, 37125463, 37125464, 37158944, 37158946, 37174350, 36672623, 36984337, 37017833, 37174338, 37174353, 37174355, 37228363; M0033PK62523002/ 37032443, 37032444, 37077341, 37228342, 37228343, 37281954, 37329456, 37329457, 37364754, 37364788, 37610411, 37777339, 37882544, 37938250, 38028262, 38028271, 38028303, 38045556, 37011644, 37017836, 37174339, 37174354, 37263855, 37263856, 37263858, 37313949, 37364768, 37479672, 37479677, 37479679, 37575306, 37644701, 37676913, 37693605, 37713605, 38000243, 38057455; M0032PK42010001/ 60200193791; M0033PK42022001/ 00193801, 00193802, 00193811, 00199272, 00199274, 60200189261; M0033PK43022001/ 60200184921, 60200184931, 60200185352, 60200186011, 60200186831, 60200191921; M0033PK62523001/ 60200191051, 60200191061; 80052/ 38134761, 38157260, 38157264, 38157268, 38157270, 38166555, 38166559, 38174961, 38185261, 38191257, 38205655, 38210562, 38221557, 38250460, 38250462, 38250463, 38290862, 38290863, 38290868, 38309361, 38311965, 38334860, 38343560, 38343561, 38363960, 38363962, 38363969, 38363970, 38371260, 38394060, 38395875, 38395880, 38408169, 38408179, 38408180, 38408185, 38408190, 38418762, 38429961, 38429971, 38439661,38453562, 38461768, 38461791, 38461792, 38476060, 38492479, 38492480, 38503762, 38503765, 38531178, 38544363, 38544364, 38557054, 38557055, 38557056, 38572773, 38572776, 38586760, 38586765, 38586767, 38586773, 38610462, 38623662, 38623663, 38623664, 38636560, 38636564, 38649866, 38660362, 38660363, 38660364, 38660365, 38660366, 38660367, 38660369, 38660370, 38671367, 38682671, 38682672, 38763862, 38131857, 38146859, 38146881, 38157255, 38157256, 38157276, 38157278, 38157279, 38166556, 38166562, 38166563, 38166564, 38166566, 38166567, 38166571, 38166572, 38166573, 38166574, 38166575, 38166576, 38166577, 38166578, 38166579, 38166580, 38166583, 38166584, 38166586, 38166587, 38166588, 38166589, 38166590, 38166591, 38166592, 38166593, 38166594, 38166595, 38166596, 38166597, 38166598, 38166599, 38166600, 38166601, 38166602, 38166605, 38166606, 38166607, 38166608, 38166609, 38166610, 38166611, 38174956, 38174966, 38174967, 38174972, 38174974, 38191271, 38195455, 38195458, 38210561, 38210565, 38210567, 38210569, 38210570, 38210572, 38210574, 38221560, 38221563, 38226159, 38226160, 38226161, 38226162, 38226163, 38226164, 38226165, 38226166, 38226167, 38226176, 38229556, 38229558, 38229576, 38239160, 38250456, 38250465, 38250470, 38250471, 38250472, 38250473, 38250474, 38250475, 38250476, 38250477, 38250478, 38250479, 38253255, 38261563, 38261564, 38261565, 38261566, 38261576, 38261577, 38271765, 38271766, 38271767, 38271768, 38271769, 38271770, 38271771, 38271772, 38271773, 38271774, 38271775, 38271776, 38271777, 38271778, 38271779, 38271780, 38271781, 38271782, 38271783, 38271784, 38271785, 38271786, 38271787, 38271788, 38271789, 38271790, 38271791, 38271792, 38271793, 38271794, 38271795, 38271796, 38271797, 38271798, 38271799, 38271800, 38271801, 38271802, 38271803, 38271804, 38271805, 38271806, 38271807, 38271808, 38271809, 38271810, 38271811, 38271812, 38281756, 38281759, 38281761, 38281766, 38311968, 38311970, 38311973, 38322364, 38322365, 38322366, 38322367, 38322368, 38322383, 38334862, 38343567, 38343568, 38343572, 38343581, 38352169, 38352171, 38363966, 38363967, 38363971, 38363972, 38363973, 38363974, 38363975, 38363976, 38363977, 38363978, 38363979, 38363980, 38377965, 38377966, 38377967, 38377968, 38377983, 38377984, 38377985, 38377986, 38395864, 38395866, 38395867, 38395886, 38408161, 38408162, 38408168, 38408183, 38408184, 38408191, 38418558, 38429960, 38429966, 38429967, 38439665, 38449963, 38449964, 38449971, 38449972, 38461767, 38461769, 38461777, 38461779, 38461780, 38461787, 38461788, 38492465, 38492467, 38492469, 38492474, 38503774, 38503775, 38516766, 38525960, 38525961, 38531162, 38531165, 38531166, 38531167, 38531168, 38531169, 38531170, 38531171, 38531172, 38531174, 38531175, 38539060, 38539061, 38544361, 38572761, 38572762, 38572763, 38572764, 38572765, 38572767, 38572770, 38572777, 38572778, 38586768, 38610460, 38610461, 38610465, 38619160, 38623660, 38623665, 38623666, 38623667, 38623668, 38623669, 38623674, 38623675, 38623676, 38623677, 38623678, 38623679, 38623680, 38623681, 38623682, 38623683, 38623684, 38623685, 38623686, 38623687, 38623688, 38636574, 38636575, 38636578, 38636579, 38636580, 38636581, 38636582, 38636585, 38649862, 38649863, 38649865, 38660361, 38660371, 38660373, 38660381, 38660382, 38671361, 38671370, 38671371, 38671372, 38671373, 38682661, 38682663, 38682664, 38682665, 38682667, 38682668, 38682670, 38682679, 38763863, 38813063, 39030961, 39030962, 39030963, 00197071, 00197072, 00199091, 00199092, 00199101, 00199102, 60200193751, 60200195801, 60200195802
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 09/21/2020, Urgent Medical Device Voluntary Recall - Removal notices were distributed to customers via courier. Risk Management/ Recall Coordinators/ Inventory Managers were asked to do the following: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to recalling firm. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 6. Inform recalling firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com) 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Email the completed form to NVCustomerCare@Stryker.com 9. Product Return Information will be provided to you by your designated Territory Manager or Sales Representative
• Quantity in Commerce: 5365
• 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, Norway, Sweden, Canada, Hong Kong, Philippines, Switzerland, Chile, Hungary, Poland, Taiwan, Colombia, India, Portugal, Thailand, Croatia, Ireland, Romania, Turkey, Czech Republic, Israel, Saudi Arabia, United Arab Emirates, Denmark, Italy, Singapore, United Kingdom, Egypt, Japan, Slovakia, Vietnam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = POL and Original Applicant = Stryker