Stryker Neurovascular: Medical Device Recall in 2024 - (Recall #: Z-1905-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 23, 2024

Date Posted: June 5, 2024

Recall Number: Z-1905-2024

Event ID: 94437

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.

Status: Ongoing

Product Quantity: 204

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.

Voluntary or Mandated:

Voluntary: Firm initiated