AQUARI IMMERSION CONTROLLER 246AQIRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842430115936), received between Oct 15, 2025 and May 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026No Audible Alarm; Protective Measures Problem

  AQUARI CONTROLLER WAS FOUND TO BE NOT PUMPING, NO ALARM. HARD REBOOT TO GET IT TO START PUMPING. THEN NOTICED PUMP WAS RUNNING CONTINUOUSLY. LEAK ISOLATED TO FOOT SECTION, REPLACED AND TESTED OK. PATIENT WAS INVOLVED, HOWEVER NO INJURY WAS REPORTED.

  Patient problems: External Prosthetic Device Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131039 ↗
• MalfunctionNov 12, 2025Device Alarm System; Break; Device Alarm System; Break

  O RINGS ON THE ENDS OF THE HOSES DETERIORATED AND BROKE APART. WITHOUT THE O RINGS, THE AQUARI PADS DO NOT MAINTAIN AIR PRESSURE AND SLOWLY DEFLATE. THIS SOMETIMES TRIGGERS THE ERROR ON THE AQUARI UNIT "PADS TOO SOFT". OTHER TIMES IT DOES NOT SEND AN ALARM AND INSTEAD THE PADS SLOWLY DEFLATE WHICH CREATES A PATIENT SAFETY RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537738 ↗
• MalfunctionOct 15, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGICAL CASE THE AQUARI PAD DEFLATED MID-PROCEDURE LEAVING THE PATIENT IN DIRECT CONTACT WITH THE METAL TABLE.

  Patient problems: Insufficient Information

  MAUDE report 23306618 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information; Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN THE PATIENT WAS REMOVED FROM PADS, IT WAS FOUND THAT THE PATIENT HAD NO SUPPORT FROM AQUARI PADS AND WAS LYING ON FLAT SURFACE. NO ALARMS HAD SOUNDED AND THERE HAD BEEN NO INDICATORS VISUALLY TO INFORM STAFF THAT THE PRODUCT WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306500 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information; Use of Device Problem; Gas/Air Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT THE END OF THE CASE, THE PADS WERE OBSERVED TO BE FLAT AND THE PATIENT WAS OPERATED ON THIS FLATTENED PAD FOR AN UNDETERMINED AMOUNT OF TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306382 ↗