Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM...
FDA Device Recall #Z-0114-2021 — Class I — September 21, 2020
Recall Summary
| Recall Number | Z-0114-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | September 21, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Neurovascular |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 5365 |
Product Description
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
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 Pattern
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
Lot / 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;
Other Recalls from Stryker Neurovascular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0021-2025 | Class II | The Trevo Trak 21 Microcatheter is a single-lum... | Aug 30, 2024 |
| Z-1903-2024 | Class II | Trevo ProVue, Catalog: 90184 | Apr 23, 2024 |
| Z-1908-2024 | Class II | DAC 044 115cm, Catalog: 90760 | Apr 23, 2024 |
| Z-1906-2024 | Class II | Trevo Trak 21 Microcatheter, Catalog: 90338 | Apr 23, 2024 |
| Z-1904-2024 | Class II | Trevo Pro 14 Microcatheter, Catalog: 90231; Tr... | Apr 23, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.