Aquamantys™ 23-313-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000280932), received between Oct 24, 2024 and Aug 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break; Mechanical Problem; No Device Output

  Information was received from a manufacturer representative regarding a handpiece. It was reported that the saline connection tube of the handpiece was torn while setting up the device before use. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208546 ↗
• MalfunctionDec 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT THE WATER WAS COMING OUT OF THE HAND PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861654 ↗
• MalfunctionJul 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE IRRIGATION LINE WAS TORN OUT. ISSUE OCCURRED PRE-OPERATIVELY AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528540 ↗
• MalfunctionJun 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE WAS FOUND TO HAVE A HOLE IN THE TUBING AFTER FUNCTIONING WITHOUT ISSUE FOR A PERIOD OF TIME. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156679 ↗
• MalfunctionMay 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE WATER WAS COMING OUT OF THE LINE. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067520 ↗
• MalfunctionOct 24, 2024Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE PACK AGING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521493 ↗