Aquamantys™ 23-112-1 (UDI 00763000738501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000738501), received between Mar 17, 2026 and Aug 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Smoking; Noise, Audible

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a handpiece. It was reported that during an above-the-knee amputation procedure, a generator produced a loud noise during activation (other case). The generator was switched out intraoperatively, and a similar loud noise was observed with the replacement generator during activation while using the same device. A loud pump noise was also reported to be always present when the handpiece was activated. The generator was then reported to have started ¿smoking¿ while the button was pressed, and use of the device was discontinued intraoperatively after the smoking was observed. The machines were changed during the case and the device was re-primed, and the procedure was completed without further use of the device. Patient was present and unknown patient impact. Additional Information was received. It was reported that the generator would not pump fluid. The cause of the noise was the bad tubing of the handpiece. The handpiece was not stopped immediately after the noise was heard; use continued until it started smoking. The noise continued during use and activation, not just during initial

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433970 ↗
• MalfunctionMar 17, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A SURGICAL OF 3-4 MINUTES TO GET REPLACEMENT AND NO REPORTED IMPACT ON PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615165 ↗