PROCEPT BIOROBOTICS CORPORATION: Medical Device Recall in 2019 - (Recall #: Z-1110-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).

Product Classification:

Class II

Date Initiated: March 6, 2019

Date Posted: April 17, 2019

Recall Number: Z-1110-2019

Event ID: 82462

Reason for Recall:

Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.

Status: Terminated

Product Quantity: 214

Code Information:

Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234

Distribution Pattern:

Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated