Aquamantys(TM) 23-301-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000047450), received between May 24, 2019 and May 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2019Smoking; Obstruction of Flow; Smoking; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PUMP ON THE GENERATOR WAS NOT SUPPLYING SALINE. "THE" STATED THE HANDPIECES WERE ACTIVATED TO MAKE SURE THEY WORKED BEFORE USING THEM ON THE PATIENT. THE REP NOTED HE DID NOT BELIEVE IT WAS OPERATOR ERROR, BUT RATHER THE PUMP BEING BROKEN AND NOT SUPPLYING SALINE. THE REP CLARIFIED THERE WAS NO "SMOKE" BUT STEAM. IT WAS NOTED THE GENERATOR WAS STILL AT THE FACILITY NOT IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642702 ↗