medical Class II Updated 2020-06-17

INARI MEDICAL recalls Triever20 Aspiration Guide Catheter a component of FlowTriev

Recalled Product

Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, DC
Lot/Code Info: Lot: 20010004, 20010005, 20010008
View official government recall

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