AquaBeam Handpiece — Class II medical device recall Z-1110-2019
Terminated recall by PROCEPT BIOROBOTICS CORPORATION, reported 2019-04-17, distributed nationwide. Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. Whe
| Recall number | Z-1110-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PROCEPT BIOROBOTICS CORPORATION, Redwood City, CA, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2019-04-08 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, ES, FR, GB, IT, PL |
| Quantity | 214 |
| Reason classes | packaging |
| Lot numbers | 18C00681, 18C00770, 18C00799, 18C00844, 18C00852, 18C00985, 18C01024, 18C01044, 18C01234, 18C01244 |
| Model numbers | 310301, 320301 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1110-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.