Stryker Neurovascular: 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

Recall number

Z-0114-2021

Recalling firm

Stryker Neurovascular

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

Status

Terminated

Initiated

2020-09-21

Posted

2020-10-21

Terminated

2024-04-01

Reason

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.

Root 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

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

Lot, serial or model codes

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;

510(k) numbers

["K190779"]

PMA numbers

not on file

Product code

POL

Firm FEI

3008853977

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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