Aquamantys™ 23-301-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000280918), received between Apr 4, 2024 and Aug 26, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Prime” (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.

• MalfunctionAug 26, 2025Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HANDPIECE FAILED TO PRIME AND THERE WAS NO SALINE FLOW IN TUBING. INITIALLY TUBING WAS PLACED INTO THE PUMP SEGMENT AND THE PRIME BUTTON WAS PRESSED. THE PUMP SEGMENT ROLLERS WERE AUDIBLY TURNING INSIDE BUT THERE WAS NO FLUID MOVEMENT. THE PRIME FEATURE WAS STOPPED AND THE TUBING WAS REMOVED FROM THE PUMP. TROUBLESHOOTING METHODS WERE PERFORMED WITH TUBING REMOVED AND PRIME BUTTON PRESSED BRIEFLY WITH THE PUMP SEGMENT OPEN TO VISUALLY INSPECT MOVEMENT OF THE ROLLERS (NO ISSUE NOTED), THE IV BAG WAS SQUEEZED BUT NO FLUID WAS PASSING THROUGH THE TUBING, A NEW 1000ML BAG OF SALINE WAS SPIKED AND THE DRIP CHAMBER WAS SQUEEZED BUT DID NOT MOVE FLUID DOWN THE TUBING, A FINAL ATTEMPT WAS MADE BY PLACING THE TUBING BACK INTO THE PUMP SEGMENT BUT THE TUBING WOULD NOT PRIME OR DELIVER FLUID TO THE TIP OF THE DEVICE. FAILED TO RESOLE THE ISSUE AFTER MULTIPLE ATTEMPTS. A NEW HANDPIECE WAS DELIVERED TO THE STERILE FIELD AND THEN CONNECTED TO THE AEX GENERATOR, IT WORKED WITHOUT ISSUE. NO REPORTED IMPACT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892147 ↗
• InjuryApr 4, 2024Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT HAD SUPERFICIAL BURNS FROM HOT SALINE. THE SURGEON NOTED THAT THE BURN ON THE LEFT IMF FROM THE HANDPIECE HAD HEALED IN 2/3 BUT NOT IN 1/3 AND WOULD REQUIRE A SURGICAL SCAR REVISION AT A LATER DATE. IT WAS ALSO NOTED THAT THE ISSUE WAS NOT WITH THE PRODUCT BUT WAS USER ERROR.

  Patient problems: Burn(s)

  MAUDE report 19044765 ↗