FDAMarch 6, 2019device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
procept bioroboticsprocept
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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