Aquamantys™ 23-112-1 (UDI 00763000280888)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000280888), received between Mar 3, 2021 and Sep 2, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break; Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571662 ↗
• MalfunctionOct 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THERE WAS A HOLE IN THE SALINE TUBING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357640 ↗
• MalfunctionAug 26, 2025Break; Break

  IT IS REPORTED THAT WHILE PREPARING FOR A PROCEDURE THERE WAS A CRACK IN THE TUBE THAT CAUSED SALINE TO LEAK. NO PATIENT CAME IN CONTACT WITH DEVICE AND THERE WAS NO REPORTED IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892059 ↗
• MalfunctionApr 29, 2025No Device Output; Device Damaged Prior to Use; No Device Output; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT AFTER RECEIVING FOUR QUANTITIES OF THE HANDPIECES, TWO OF THEM HAD MOLD ON THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926705 ↗
• MalfunctionApr 29, 2025No Device Output; Device Damaged Prior to Use; No Device Output; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT AFTER RECEIVING FOUR QUANTITIES OF THE HANDPIECES, TWO OF THEM HAD MOLD ON THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926613 ↗
• MalfunctionMar 27, 2025Excess Flow or Over-Infusion; Device Damaged Prior to Use; Excess Flow or Over-Infusion; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE BEING USED INTRAOPERATIVELY. IT WAS REPORTED THAT AFTER OPENING THE HANDPIECE AND PLACING IT ON THE CONSOLE THE SITE STARTED UP THE DRAINING AND TUBING AND THERE WAS A LEAK/HOLE IN THE IRRIGATION CABLE OF THE HANDPIECE CABLE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706960 ↗
• MalfunctionSep 11, 2024Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  MEDTRONIC RECEIVED INFORMATION REGARDING A HANDPIECE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE HANDPIECE PACKAGING. NO PATIENT WAS PRESENT DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190023 ↗
• MalfunctionJun 5, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT AN UNOPENED STERILE ITEM CONTAINED PIECE OF BLACK HAIR IN THE PACKAGING. THIS ITEM WAS PULLED FROM STOCK WHEN THE ISSUE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467864 ↗
• MalfunctionApr 24, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR PREOPERATIVELY. IT WAS REPORTED THAT HAIR WAS FOUND IN STERILE PACKAGING. THE HANDPIECE WAS NOT USED. ANOTHER PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173422 ↗
• MalfunctionApr 16, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE TUBING WAS BROKEN UPON OPENING. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117754 ↗
• MalfunctionOct 23, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS A HAIR IN THE PACKAGING THAT WAS NOTICED IT WHILE SETTING UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985871 ↗
• InjuryJul 14, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  2023-SEP-19 E1 (HCP): NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 17329564 ↗
• MalfunctionJul 13, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE BELIEVES THE FRONT PUMP ON THEIR GENERATOR SYSTEM WAS CAUSING THE TUBE ON THEIR HANDPIECE TO BREAK. THE SITE STATED THAT THIS HAPPENED TWICE IN TWO SEPARATE CASES. THE OR STAFF NOTICED THAT THE TUBING WAS DAMAGED DURING THE CASE, SO IT WAS REPLACED. THERE WAS A DELAY OF LESS THAN 1 HOUR AND THE PATIENT WAS REPORTEDLY AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317279 ↗
• MalfunctionMar 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT "ONE OF THE GOLD PRONGS ON THE HANDPIECE WAS BENT AND WAS NOT ABLE TO FIT INTO MACHINE ". THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496537 ↗
• MalfunctionMar 3, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE SITE RECEIVED A HANDPIECE AND ITS STERILE SEAL WAS BROKEN. IT WAS NO LONGER STERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405910 ↗