The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2330-2021·Announced 2021-09-01

AQUABEAM Handpiece scope tube tip may detach during procedures

PROCEPT BIOROBOTICS is recalling AQUABEAM Handpieces (model HP2000) because the scope tube tip may detach during use, potentially requiring procedural delay or additional intervention to remove the tip from the bladder or prostate.

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: Class II FDA medical device with documented failure mode (scope tube tip detachment) that can necessitate additional clinical intervention. No injuries have been reported, but the potential for patient impact—including procedural delay and possible foreign body retention requiring removal—meets the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

PROCEPT BIOROBOTICS CORPORATION is recalling the AQUABEAM Handpiece, model HP2000, a sterile single-use component of the AQUABEAM Robotic System. The recall affects 608 units with worldwide distribution across multiple U.S. states and international countries including Austria, Switzerland, Germany, Spain, France, United Kingdom, and Italy.

The scope tube tip may detach from the telescoping tube during medical procedures. Tip detachment can delay the procedure and may require handpiece exchange. In some cases, the tip may completely separate from the handpiece and remain in the bladder or prostate, potentially necessitating removal through additional intervention.

Healthcare facilities and clinical providers using the affected product should verify their inventory against the recalled lot numbers: 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, 21C00527. Patients who underwent procedures with affected handpieces should consult with their healthcare provider if they have any concerns or symptoms.

The recalled product

Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Manufacturer
PROCEPT BIOROBOTICS CORPORATION
Category
Medical Device — Urological Surgical Equipment
Hazard
Affected units
608

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 (8)

  • Lot: 21C00226
  • 21C00290
  • 21C00304
  • 21C00359
  • 21C00373
  • 21C00464
  • 21C00465
  • 21C00527

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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