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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PROCEPT BIOROBOTICS CORPORATION
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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).
Product Codes/Lot Numbers:
Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1110-2019
Related Recalls
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
PROCEPT BIOROBOTICS
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.