Reported Sep 1, 2021 · Ongoing
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Procept Biorobotics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PROCEPT BIOROBOTICS CORPORATION · 900 Island Dr Ste 101 · Redwood City, CA · 94065-5176
Is this the product you have?
- AQUABEAM Handpiece
- REFHP2000, a sterile single-use component of the AQUABEAM Robotic System
- Lot codes and dates
- Lot
21C0022621C0029021C0030421C0035921C0037321C0046421C0046521C00527
- Lot
- Amount recalled
- 608
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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