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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94437

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 23, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Neurovascular

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK, Catalog: 80052 TREVO XP 4X30+PRO18 2-PACK, Catalog: 93067 TREVO XP 6X25+XT27 2-PACK, Catalog: 93068 TREVO XP 3X20+PRO14+CAT6 3-PACK - CE, Catalog: M0033PK32021002 TREVO XP 4X20+PRO18+CAT6 3-PACK - CE, Catalog: M0033PK42022002 TREVO XP 6X25+XT27+CAT6 3-PACK - CE, Catalog: M0033PK62523002

Z-1902-2024
Recall number
Z-1902-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
461

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog/UDI-DI/Lot: 90182/00815742001822/116706; 90183/00815742001839/117514; 90185/00815742001853/118900; 90186/00815742001860/114054; 80051/00815742000511/47307561, 47328877, 47351811, 47398058, 47398074, 48521577, 48521585, 48540280, 48540281, 48540282, 48540283, 48540284, 48556786, 48588490, 48607589, 48676218, 48696629, 48715720, 48736116, 48736122, 48754915, 48754920, 48772012, 48772014, 48772025, 50065499, 50065511, 50065512, 50065513, 50065514, 50065515, 50065518, 50113384, 50113385, 50133176, 50133191, 50193582, 50216273, 50216274, 50216277, 50239676, 50260575, 50260583, 50280979, 50281011, 50304688, 50304712, 50304713, 50304714, 50397877, 50422572, 50422582, 50422589, 50448279, 50519274, 50519275, 50519276, 50519277, 50519285, 50519295, 50577572, 50607374, 50607376, 50607377, 50607378, 50650278, 50650279, 50650288, 50673881, 50673884, 50673908, 50673909, 50673910, 50673911, 50673930, 50694279, 50738912, 50786710, 50850697, 50869887, 50869892, 50869905, 50886487, 50912493, 50912514, 50912515, 50912516, 50912517, 50931490, 50931518, 50931519, 50950402, 50967093, 51320497, 51350503, 51350505, 51489228, 51489235, 51513311, 51513516, 51535421, 51729133; 80052/00815742000528/49021114, 49021115, 49021116, 49021117, 49021118, 49033114, 49033115, 49033116, 49033117, 49052517, 49052525, 49192125, 49192140, 49192141, 49216723, 49216724, 49216737, 53175402; 93067/00815742000672/53320201; 93068/00815742000689/48963313, 49056315, 49155966, 49216725, 49318831, 49318836, 49318837, 49418740, 49418743, 49441346, 50000932, 50000933, 50000934, 50029333, 50029340, 50029361, 50047054, 50065482, 50065485, 50065486, 50065487; M0033PK32021002/07613327126334/48500990, 48624226, 48641523, 48641533, 50156372, 50519272, 50650290, 50912513, 50967091; M0033PK42022002/07613327126358/48995917, 49033123, 49140624, 49236926; M0033PK62523002/07613327126365/49033118, 49236935, 50047053

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 2 of 8

Trevo ProVue, Catalog: 90184

Z-1903-2024
Recall number
Z-1903-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog: 90184, UDI-DI: 00815742001846, Lot: 118117, 118420, 118833

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 3 of 8

Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238

Z-1904-2024
Recall number
Z-1904-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
648

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog/UDI-DI/Lot: 90231/00815742002317/121050, 129849, 129882, 130285, 136439, 136628, 143375, 143476; 90238/00815742002386/136009, 198334

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 4 of 8

Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190

Z-1905-2024
Recall number
Z-1905-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
204

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog/UDI-DI/Lot: 90312/07613327299922/118881; 91412/07613327500684/48483279, 48483281, 48483294, 48696618, 48696619, 48696620, 48715713, 48834692, 48834695, 48834696; 91413/07613327500691/48483280, 48483284, 48483289, 48483291, 48483316, 48483317, 48696613, 48696622, 48696623, 48715711, 48715715; 91414/07613327500707/48447776, 48447778, 48447779, 48483290, 48483292, 48483293, 48483315, 48483318, 48483320, 48696624, 48715714, 48834690, 48834691, 48834694, 48834697, 48852726, 48852730, 48852731, 48852732, 48852734, 48852735, 48852737, 48852738; 91415/07613327500714/48483277, 48483283, 48483295, 48483296, 48483311, 48483312, 48696621, 48715712, 48715716, 48834688, 48834693, 48834698; 91416/07613327507904/47328863, 47328865, 47351815, 47351816, 47374814, 48500988, 48501006, 48501007, 48501008, 48501009, 48501010, 48501011, 48501012, 48501013, 48501014, 48540277, 48556780, 48556783, 48558375, 48588482, 48589876, 48641524, 50065509, 50065520, 50193572, 50260581, 50327385, 50327403, 50375186, 50375187, 50422577, 50422588, 50448274, 50738892, 50762691, 50762721, 50762722, 50786687, 50797491, 50797494, 50797495, 50886508, 51320490, 51320491, 51379394, 51379399, 51379400, 51379401, 51379402, 51379403, 51379404, 51379405, 51379406, 51379408, 51467927, 51489221, 51489230, 51489233, 51489234; SFP914170/07613327508055/48834689; SFP914190/07613327508079/48945914

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 5 of 8

Trevo Trak 21 Microcatheter, Catalog: 90338

Z-1906-2024
Recall number
Z-1906-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
899

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog: 90338, UDI-DI: 07613327313956, Lot: 119461, 119473, 119598, 120070, 120201, 120970, 140512, 136912, 136913, 136914, 136915

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 6 of 8

FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

Z-1907-2024
Recall number
Z-1907-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
2579

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog/UDI-DI/Lot: 90485/00815742004854/213869; 90495/00815742004953/134165, 134840, 135021, 138245, 172663, 172664, 173281, 175682, 176460, 176461, 177614, 178201, 178720, 213152

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 7 of 8

DAC 044 115cm, Catalog: 90760

Z-1908-2024
Recall number
Z-1908-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
81

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog: 90760, UDI-DI: 07613327313918, Lot: 156628

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

device · product 8 of 8

Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330

Z-1909-2024
Recall number
Z-1909-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Neurovascular
Quantity
2859

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Code information

Catalog/UDI-DI/Lot: M00313010/07613252186922/123279, 123364, 123404, 123985, 124214, 124216; M00313310/07613252186946/123494; M00316310/07613252187158/123851; M00316330/07613252187165/124156

Distribution pattern

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.