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

Recall date

July 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2330-2021

FDA classification

Class II

Brand / firm

PROCEPT BIOROBOTICS CORPORATION

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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