Mon-a-Therm 90051Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30884521078028), received between Jun 7, 2018 and May 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD BROKEN BALLOON WHEN IDC REMOVED ON 2 CATHETERS. FIRST IDC INSERTED AT START OF SURGERY, NO URINE OUTPUT WHEN PATIENT ARRIVED. SECOND IDC INSERTED AND REMOVED AS BROKEN BALLOON. CATHETER BALLOON WAS TESTED AND FOUND TO BE LEAKING. BLADDER SCAN WAS ATTENDED, 650 ML IN BLADDER. THEN REQUIRED 2 IDC INSERTION SET UPS AS 2ND IDC BALLOON BROKE. THE PATIENT EXPERIENCED PAIN AND DISCOMFORT.

  Patient problems: Pain

  MAUDE report 14497040 ↗
• MalfunctionJun 10, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LIQUID LEAKAGE AND FOUND THAT THE BALLOON WAS BROKEN. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682587 ↗
• MalfunctionAug 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A FALSE MEASUREMENT OF TEMPERATURE, WHEREIN THE CATHETER TEMPERATURE WAS 36.4 AND IN THE CONTROL RECTALLY 39.5, THEN A FURTHER TEMPERATURE CONTROL WAS PERFORMED IN THE GROIN WITH A RESULT OF 39.0. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 7814358 ↗
• MalfunctionJun 7, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS LEAKING LIQUID. IT WAS ALSO STATED THAT AFTER CLEANING OF THE DEVICE, THEY NOTICED A LITTLE HOLE IN IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7578054 ↗