Recall Z-2299-2020— INARI MEDICAL
Class II · Terminated
Class II FDA medical device recall by INARI MEDICAL, initiated 2020-03-23, terminated 2021-08-13. It names one FDA 510(k) clearance: K182233. Product: Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079. 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..
- Recalling firm
- INARI MEDICAL
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-23
- Terminated
- 2021-08-13
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.