Recall
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
PROCEPT BIOROBOTICS CORPORATION · 9 July 2021
- Status
- Recall open, classified
- Why, in the FDA's words
- “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.”
- Recall began
- 9 July 2021
- Company
- PROCEPT BIOROBOTICS CORPORATION
- Device type
- Product code (PZP)
- Concerns
- K202961
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.