Procept recalls AQUABEAM HP2000 handpieces due to risk of tip detachment causing procedural delays. Affected units have specific lot numbers. Contact for replacement.
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.
Procept is recalling AQUABEAM HP2000 handpieces because the scope tube tip can detach during use, potentially causing delays in medical procedures. This risk is specific to the sterile single-use component used in robotic surgery systems.
The scope tube tip can detach from the telescoping tube during surgery, which may require removing the tip from the bladder or prostate. This detachment can cause procedural delays and may necessitate additional steps to replace the handpiece.
Patients undergoing robotic-assisted urological procedures using the AQUABEAM system are most at risk. Healthcare providers using the HP2000 handpiece in these procedures may need to adjust their workflow.
Check for lot numbers 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, or 21C00527 on the handpiece packaging. The AQUABEAM HP2000 is a sterile single-use component for robotic surgery systems.
Verify if your handpiece has any of the listed lot numbers: 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, or 21C00527.
The scope tube tip may detach from the telescoping tube during use, which can cause procedural delays and may require removing the tip from the bladder or prostate.
Check if your handpiece has one of the listed lot numbers. If it does, contact Procept for replacement or further instructions.
Yes, tip detachment can cause procedural delays and may necessitate removing the tip from the bladder or prostate, which could impact surgery timing.
We’ve drafted a message you can send Procept Biometrics to request your refund or repair — edit it as you like.
Subject: Recall Z-2330-2021 — Procept Biometrics Procept Biometrics Hello, I own a Procept Biometrics that is covered by recall Z-2330-2021 from Procept Biometrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
