Zvu® HRIM-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816734022689), received between Jan 6, 2025 and Jan 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 6, 2025No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  DESCRIPTION FROM MW5162137 VOLUNTARY USER REPORT: PRIOR TO PATIENT: PROBE WAS TESTED UNDER THE CALIBRATION PROCESS AND APPEARED TO BE IN WORKING ORDER. ALL SENSORS WERE GREEN WHICH INDICATED ALL SENSORS WERE WORKING PROPERLY. PROBE INSERTED INTO NARE WITHOUT DIFFICULTY. DATA REFLECTED ON SCREEN SHOWED THAT PROBE NEEDED INSERTED MORE AND THAT THERE WAS POSSIBLE COILING. PULLED PROBE OUT APPROXIMATELY 6 CM (IN ORDER TO FIX POSSIBLE COILING) AND THEN ADVANCED PROBE. PATIENT TOLERATED WELL. STILL DID NOT SEE ACCURATE DATA ON THE MONITOR (NEEDED ADVANCED MORE TO SEE THE OUTFLOW PORTION OF THE SWALLOW). SAT PATIENT UP TO ATTEMPT BETTER PLACEMENT AGAIN. PULLED PROBE OUT APPROXIMATELY HALFWAY AND PATIENT POINTED TO MOUTH (PROBE WAS NOW COILED IN HER MOUTH AFTER SOME MILD COUGHING/GAGGING). IT WAS DECIDED TO COMPLETELY REMOVE THE PROBE IN ORDER TO TRY A SECOND ATTEMPT. ONCE PROBE WAS REMOVED IT WAS IMMEDIATELY NOTICED THAT IT WAS BROKEN. PATIENT TOLERATED WELL. NO VISIBLE BLEEDING FROM MOUTH/NARES. SMALL AMOUNT OF BLOOD WAS NOTED ON PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084847 ↗