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 Scope tube tip may detach from the telescoping...
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, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Quantity: 608
Why Was This 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.
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