PROCEPT BIOROBOTICS CORPORATION: Medical Device Recall in 2021 - (Recall #: Z-2330-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 9, 2021

Date Posted: September 1, 2021

Recall Number: Z-2330-2021

Event ID: 88337

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.

Status: Ongoing

Product Quantity: 608

Code Information:

Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated