Trevo ProVue, Catalog: 90184
Reported: June 5, 2024 Initiated: April 23, 2024 #Z-1903-2024
Product Description
Trevo ProVue, Catalog: 90184
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.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 280
- Distribution
- 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.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
Trevo ProVue, Catalog: 90184. Recalled by Stryker Neurovascular. Units affected: 280.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1903-2024.
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