# FDA recall Z-2299-2020

> **INARI MEDICAL** · Class II · device recall initiated 2020-03-23.

## Product

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2299-2020
- **Recalling firm:** INARI MEDICAL
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-23
- **Report date:** 2020-06-17
- **Termination date:** 2021-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2299-2020

## Citation

> AI Analytics. FDA recall Z-2299-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2299-2020. Source: US FDA. Licensed CC0.

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