# FDA recall Z-2080-2019

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2018-06-25.

## Product

POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA  Kit;   POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit;   POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit;   POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit;   NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded  Software, Patient Module, and ECG Cable)    Product Usage:  Is an implantable access device designed to provide repeated access to the vascular system.

## Reason for recall

Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.

## Distribution

US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA

## Key facts

- **Recall number:** Z-2080-2019
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-06-25
- **Report date:** 2019-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2080-2019

## Citation

> AI Analytics. FDA recall Z-2080-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2080-2019. Source: US FDA. Licensed CC0.

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