Z-2330-2021Class II

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System

Name: Z-2330-2021 AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System
Creator: Procept Biorobotics Corporation
Published: 2021-07-09
License: https://open.fda.gov/license/

PROCEPT BioRobotics Corporation / initiated 2021-07-09 / Open, Classified

FDA source

PROCEPT BIOROBOTICS CORPORATION began a recall of AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System on 2021-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2330-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-09
Posted: 2021-08-20
Recalling firm: PROCEPT BioRobotics Corporation
Product: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Product code: PZP Fluid Jet Removal System
Reason for recall: 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.
FDA root cause: Component change control
Action: On 07/09/21 Voluntary Medical Device Recall notices were mailed to customers. Customers were asked to take the following actions if tip detachment occurs: If the scope tube tip detaches from the telescoping tube before insertion into the patient during preparation, the Handpiece must be replaced with a new Handpiece. If the scope tube tip detaches after the Handpiece has been inserted into the patient, this is seen cystoscopically and the Handpiece must be removed and replaced with a new Handpiece. In the event that the scope tube tip separates from the Handpiece entirely, the scope tube tip may fall into the bladder or the prostate. The standard 26Fr resectoscope, used in an Aquablation procedure, will accommodate the removal of the detached scope tube tip. In addition, customers were asked to take the following actions: 1) Read the notice. 2) Stop using affected devices. 3) Remove affected lots from their regular inventory location and segregate for future return and replacement. 4) Complete and return the acknowledgement form. 5) Pass along the notice to all that need to be aware. Customers with questions were encouraged to contact Customer Service: 1.650.232.7222 or e-mail [email protected].
Quantity in commerce: 608
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.
Product codes and lots: Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-20

Product code PZP

K202961Class IIAquaBeam Robotic SystemProcept Biorobotics, Corporation / cleared 2021-03-11

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)