FDA Medical Device Recalls (openFDA)
PROCEPT BIOROBOTICS CORPORATION: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
- Recall number
- Z-2330-2021
- Recalling firm
- PROCEPT BIOROBOTICS CORPORATION
- Product
- AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
- Status
- Open, Classified
- Initiated
- 2021-07-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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 cs@procept-biorobotics.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527
- 510(k) numbers
- ["K202961"]
- PMA numbers
- not on file
- Product code
- PZP
- Firm FEI
- 3027788423
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28