FDA-Device2020-06-17Class II
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
INARI MEDICAL
Hazard
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
Sold states
U.S Distribution in the states of .: IA, GA, MO, MI, AZ, FL, NJ, MN, LA, PA, AL, OH, NY, WI, CA, TX, TN, NH, IL, NC, CT, CO, OK, OR, IN, MA, VA, KY, WA, MS, SC, UT, SD, ND, AR, ID, DE, including DC.
Affected count
318
Manufactured in
9 Parker Ste 100, N/A, Irvine, CA, United States
Products
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2299-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief