Z-1902-2024 Class II Ongoing
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
- 461
Product Description
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
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: 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