medical Class II Updated 2021-09-01

PROCEPT BIOROBOTICS CORPORATION recalls AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon

Recalled Product

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527
View official government recall

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