Z-1110-2019Class II

AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System...

Name: Z-1110-2019 AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System...
Creator: Procept Biorobotics Corporation
Published: 2019-03-06
License: https://open.fda.gov/license/

PROCEPT BioRobotics Corporation / initiated 2019-03-06 / Terminated / root cause: manufacturing process

FDA source

PROCEPT BIOROBOTICS CORPORATION began a recall of AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device... on 2019-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1110-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-06
Posted: 2019-04-08
Terminated: 2020-11-13
Recalling firm: PROCEPT BioRobotics Corporation
Product: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
Product code: PZP Fluid Jet Removal System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/06/19, the firm, Procept BioRobotics, sent an"URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter via priority overnight mail with delivery confirmation to customers with affected devices. The letter the described the product, problem and actions to be taken. Customers were instructed to discontinue use and segregate affected devices. In addition, customers were asked to pass along the recall notice to all those who need to be aware of it within their organization and to complete and return the Recall Acknowledgement Form via Email: [email protected] or Fax to: +1.888.285.3777. Once the firm receives acknowledgement forms listing affected product, the firm will provide instructions on how to return affected product. Customers with questions are encouraged to call customer service at 1-650-232-7222. On 03/06/19, Courtesy Notification: Voluntary Medical Device Recall notices were mailed via priority overnight mail with delivery confirmation to customers who received non-affected devices. Customers who did not receive affected product were advised that no actions needed to be taken. Customers with questions are encouraged to call customer service at 1-650-232-7222. If you have any questions, please feel free to contact your local Aquablation Consultant or PROCEPT Customer Service by telephone at +1.650.232.7222 or email [email protected].
Quantity in commerce: 214
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.
Product codes and lots: Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1110-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1110-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08

Product code PZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)