{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184096", "product_res_number": "Z-0114-2021", "event_date_initiated": "2020-09-21", "event_date_posted": "2020-10-21", "recall_status": "Terminated", "event_date_terminated": "2024-04-01", "res_event_number": "86583", "product_code": "POL", "k_numbers": [ "K190779" ], "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", "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, 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;", "firm_fei_number": "3008853977", "recalling_firm": "Stryker Neurovascular", "address_1": "47900 Bayside Pkwy", "city": "Fremont", "state": "CA", "postal_code": "94538-6515", "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.", "root_cause_description": "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:\n1. Immediately check your internal inventory for affected devices.\n2. Segregate the affected units in a secure location for return to recalling firm.\n3. Circulate this Recall-Removal notice internally to all interested/affected parties.\n4. Maintain awareness of this communication internally until all required actions have been completed within your facility.\n5. 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.\n6. 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)\n7. 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\nupdate our records and will also negate the need for us to send any further unnecessary communications on this matter.\n8. Email the completed form to NVCustomerCare@Stryker.com\n9. Product Return Information will be provided to you by your designated Territory Manager or Sales Representative", "product_quantity": "5365", "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.\n\nForeign: 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", "openfda": { "k_number": [ "K222848", "DEN150049", "K183022", "K173352", "K181060", "K242676", "K200117", "K210502", "K203219", "K231539", "K181186", "K203358", "K193576", "K190779", "K162539", "K223305", "K181807", "K192207" ], "registration_number": [ "1721676", "3015550451", "2011171", "3007007790", "3009380063", "3013656790", "3008853977", "2029214", "3016540856", "3012497308", "3012931345", "3031288142", "3006451981" ], "fei_number": [ "1721676", "3015550451", "1000220862", "2011171", "3007007790", "3009380063", "3013656790", "3008853977", "3016540856", "3012497308", "3012931345", "3031288142", "3006451981" ], "device_name": "Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment", "medical_specialty_description": "Neurology", "regulation_number": "882.5600", "device_class": "2" } } ] }