Use caution Medical device recall · FDA · Published March 6, 2019

Procept AquaBeam Handpiece Recall: Internal Leak Risk in Certain Lots

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1110-2019Medical device Procept Biometrics ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmPROCEPT BIOROBOTICS CORPORATION900 Island Dr Ste 101 · Redwood City, CA 94065-5176

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/68910-procept-aquabeam-handpiece-recall-internal-leak-risk-in-certain-lots.

Source Summary by GovInfoNow · govinfonow.com/recall/68910-procept-aquabeam-handpiece-recall-internal-leak-risk-in-certain-lots · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1110-2019

Cite this page

“Procept AquaBeam Handpiece Recall: Internal Leak Risk in Certain Lots.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68910-procept-aquabeam-handpiece-recall-internal-leak-risk-in-certain-lots. Based on FDA recall #Z-1110-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2019%22&limit=1).

The FDA announced on March 6, 2019, that Procept Biometrics recalled AquaBeam Handpieces due to potential internal leaks. The agency issued recall number Z-1110-2019 for the device component.

How to tell if you have it

Brand: Procept Biometrics
Product: AquaBeam Handpiece, Sterile EO, Rx Only
REF: 310301 and 320301
Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244
Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234
Units affected: 214

The hazard

Context

GovInfoNow's records show Procept Biometrics has one other recall on record since July 9, 2021. Other recent recalls of similar products include Stryker Irrigator Leaks During Use (June 8, 2026), Abiomed Impella CP Smart Assist Set Recall (June 11, 2026), and Abiomed Heart Pump Kit Recall (June 11, 2026).

How to tell if you have this one

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.

Brand
Procept Biometrics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers 18C00681, 18C00770, 18C00852, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234, or 18C01244 on the device packaging.
Monitor for Error Messages
If the device shows an error message indicating a failure, it may have developed an internal leak and should not be used.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA distribution: “Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Illinois, Indiana, Michigan, Pennsylvania, Texas, Virginia.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Mar 6, 2019Firm started the recall
Apr 8, 2019FDA classified it Class II
Apr 17, 2019Published in FDA’s Enforcement Report
Nov 13, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the AquaBeam Handpiece used for?

The AquaBeam Handpiece is a component of the AquaBeam Robotic System for treating lower urinary tract symptoms from benign prostatic hyperplasia (BPH).

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Link to this recall

<a href="https://govinfonow.com/recall/68910-procept-aquabeam-handpiece-recall-internal-leak-risk-in-certain-lots">Procept AquaBeam Handpiece Recall: Internal Leak Risk in Certain Lots (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1110-2019 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1110-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.