Aquamantys™ 23-113-1 (UDI 00763000738556)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000738556), received between Jul 16, 2025 and Sep 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 18, 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.

• MalfunctionSep 8, 2026Mechanical Problem

  Information was received from a manufacturer representative regarding a handpiece. It was reported that the packaging of a new handpiece was damaged upon arrival and sterility was compromised. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669404 ↗
• MalfunctionJul 16, 2025Material Puncture/Hole

  DURING THE CASE, IT WAS DISCOVERED THAT THE AQUAMANTYS TUBING HAD A HOLE IN THE LINE. THE AQUAMANTYS WAS DRIPPING ONTO THE FLOOR AND THE IRRIGATION FROM THE BAG HAD BEEN USED TO IRRIGATE AN INTEGRA PATCH FOR IMPLANTATION. THE TUBING WAS NOT SAVED AFTER THE PROCEDURE AND THE OR MANAGER SUBMITTED A TICKET FOR BIOMED DEPT INVESTIGATION OF THE AQUAMANTYS MACHINE AS THE HOLE IN TUBING WAS WITHIN THE MACHINE ITSELF - PENDING FEEDBACK FROM BIOMED DEPT. AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518725 ↗