# FDA recall Z-1146-2018

> **Vascular Insights, LLC** · Class II · device recall initiated 2017-11-09.

## Product

ClariVein IC infusion catheter, Model Number: 65-018-E4S    Product Usage:  The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

## Reason for recall

Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

## Distribution

U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA

## Key facts

- **Recall number:** Z-1146-2018
- **Recalling firm:** Vascular Insights, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-09
- **Report date:** 2018-03-28
- **Termination date:** 2018-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Quincy, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2018

## Citation

> AI Analytics. FDA recall Z-1146-2018. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1146-2018. Source: US FDA. Licensed CC0.

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