# FDA recall Z-2330-2021

> **PROCEPT BIOROBOTICS CORPORATION** · Class II · device recall initiated 2021-07-09.

## Product

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

## Reason for recall

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.

## Key facts

- **Recall number:** Z-2330-2021
- **Recalling firm:** PROCEPT BIOROBOTICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-09
- **Report date:** 2021-09-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2021

## Citation

> AI Analytics. FDA recall Z-2330-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2330-2021. Source: US FDA. Licensed CC0.

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