Home / Recalls / Stryker Neurovascular / Z-1909-2024

Z-1909-2024 Class II Ongoing

Recalled by Stryker Neurovascular — Fremont, CA

Recall Details

Product Type
Devices
Report Date
June 5, 2024
Initiation Date
April 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2859

Product Description

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

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.

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.

Code Information

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

Other recalls by Stryker Neurovascular

  • Z-0021-2025 Class II — The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiff (August 30, 2024)
  • Z-1904-2024 Class II — Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog (April 23, 2024)
  • Z-1903-2024 Class II — Trevo ProVue, Catalog: 90184 (April 23, 2024)
  • Z-1908-2024 Class II — DAC 044 115cm, Catalog: 90760 (April 23, 2024)
  • Z-1902-2024 Class II — Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x (April 23, 2024)
  • Z-1905-2024 Class II — Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PA (April 23, 2024)
  • Z-1906-2024 Class II — Trevo Trak 21 Microcatheter, Catalog: 90338 (April 23, 2024)
  • Z-1907-2024 Class II — FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 (April 23, 2024)
  • Z-1940-2024 Class II — The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable (April 18, 2024)
  • Z-1939-2024 Class II — The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable t (April 18, 2024)