Procept recalls specific lots of AquaBeam Handpiece (REF 310301, 320301) due to potential internal leaks from weld joint cracks. The device may become inoperable with error messages during use.
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
Procept is recalling certain lots of AquaBeam Handpiece (REF 310301 and 320301) because they may have a micro-crack in the weld joint that causes internal leaks. This could lead to the device becoming inoperable during medical procedures with error messages.
The device may develop a micro-crack in a weld joint, causing internal leaks. When the robot detects this failure, it shuts down the device and shows an error message, which could delay or prevent completing the procedure.
Patients using the AquaBeam Robotic System for BPH treatment in the U.S. and certain foreign lots. Medical professionals who operate the device are most at risk.
Check for lot numbers 18C00681, 18C00770, 18C00852, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234, 18C01244. The device is labeled as 'AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301 or 320301' and is part of the AquaBeam Robotic System for BPH treatment.
Look for lot numbers 18C00681, 18C00770, 18C00852, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234, or 18C01244 on the device packaging.
If the device shows an error message indicating a failure, it may have developed an internal leak and should not be used.
The AquaBeam Handpiece is a component of the AquaBeam Robotic System for treating lower urinary tract symptoms from benign prostatic hyperplasia (BPH).
Domestic lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234.
The recall does not specify a remedy, so contact Procept Biometrics for guidance on next steps.
We’ve drafted a message you can send Procept Biometrics to request your refund or repair — edit it as you like.
Subject: Recall Z-1110-2019 — Procept Biometrics Procept Biometrics Hello, I own a Procept Biometrics that is covered by recall Z-1110-2019 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.
