# FDA recall Z-0489-2021

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2020-10-23.

## Product

Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target.    User Manual:  ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12

## Reason for recall

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

## Distribution

US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.

## Key facts

- **Recall number:** Z-0489-2021
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-02
- **Termination date:** 2022-12-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2021

## Citation

> AI Analytics. FDA recall Z-0489-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0489-2021. Source: US FDA. Licensed CC0.

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