FDA-Device2020-10-28Class I
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
Stryker Neurovascular
Hazard
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.
Sold states
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. Foreign: 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
Affected count
5365
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2021Don't want to check this manually?
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