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Recall Observatory FDA recall evidence

Device product

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

Z-2299-2020

March 23, 2020

Class II

Product summary

Firm
INARI MEDICAL
Event
Event 85424
Status
Terminated
Classification
Class II
Quantity
318
Official record key
device-enforcement:Z-2299-2020

Official wording

Reason: 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.

Code information: Lot: 20010004, 20010005, 20010008

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.