FDAJuly 9, 2021device
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
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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