FDA Device recall Z-2330-2021
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System
- FDA Device
- Class II
- ongoing
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System by Procept Biorobotics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2330-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-09 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Procept Biorobotics |
| Distribution | US |
Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
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.
Identifiers
| code_info | Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2330-2021%22
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