Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AquaBeam Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to Certain lots may develop an internal leak due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PROCEPT BIOROBOTICS CORPORATION directly.
Affected Products
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).
Quantity: 214
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PROCEPT BIOROBOTICS CORPORATION
PROCEPT BIOROBOTICS CORPORATION has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report