Procept Biorobotics Recalls AquaBeam Handpieces Due to Potential Internal Leaks
Procept Biorobotics is recalling 214 AquaBeam Handpieces because a micro-crack in a weld joint may cause an internal leak, potentially delaying or preventing the completion of medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the device failure may cause a delay or inability to complete a medical procedure, but no injuries or illnesses have been reported.
Plain-English summary
Procept Biorobotics Corporation is recalling 214 units of the AquaBeam Handpiece, a component of the AquaBeam Robotic System. The device is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH). The specific reference numbers involved are 310301 and 320301.
The recall is being conducted because certain lots of the handpiece may develop an internal leak due to a micro-crack in a specific weld joint. If this failure occurs, the robotic system detects the issue, renders the device inoperable, and notifies the user via an error message. This malfunction may cause a delay in the procedure or make it impossible to complete.
The affected units were distributed nationwide in the United States to Texas, Florida, Indiana, California, Illinois, Virginia, Michigan, and Pennsylvania. They were also distributed internationally to Italy, Germany, France, Poland, the United Kingdom, Spain, Canada, and Australia. Domestic lots include 18C00681, 18C00770, 18C00852, and 18C01244, while foreign lots include 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, and 18C01234. Healthcare providers should stop using the affected handpieces and contact the manufacturer for instructions on replacement or return.
The recalled product
- 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…
- Manufacturer
- PROCEPT BIOROBOTICS CORPORATION
- Affected units
- 214
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Domestic Lots: 18C00681
- 18C00770
- 18C00852
- 18C01244. Foreign Lots: 18C00799
- 18C00844
- 18C00985
- 18C01024
- 18C01044
- 18C01234
Distribution
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