Kendall 33135T (UDI 10192253062779)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253062779), received between Mar 11, 2026 and May 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Incorrect Interpretation of Signal

  THE CUSTOMER REPORTED AN ISSUE WITH A SINGLE-USE LEAD SET THAT WAS BEING USED ON A PATIENT POST-OP DAY (POD) 5. THEY STATED THAT THE WAVEFORM WAS EASILY DISTINGUISHED AS NON-LETHAL. ADDITIONAL INFORMATION RECEIVED ON 05MAY2026 STATED THAT THE ERRONEOUS READING HAD HAPPENED SEVERAL TIMES OVER THE COURSE OF THE NIGHT FOR SHORT PERIODS. THE REPORTER WAS UNSURE IF IT ALARMED FOR VTACH. SHE STATED THAT IT IS QUITE POSSIBLE THAT THEY WERE ALARMING FOR VTACH AT ONE POINT OR ANOTHER, BUT THE LEADS WERE REPLACED BASED ON CLEARLY INACCURATE TRACINGS. IT WAS ALSO STATED THAT SINCE THEY WERE INTERMITTENTLY READING NORMAL SINUS RHYTHM, AND THE PATIENT WAS VERY CLEARLY NOT IN ANY DISTRESS, THEY DID NOT REQUIRE A FULL EKG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257451 ↗
• MalfunctionApr 30, 2026Incorrect Interpretation of Signal

  THE CUSTOMER REPORTED THAT THEY ENCOUNTERED AN ISSUE WITH A SET OF DISPOSABLE LEADS THE MORNING OF (B)(6) 2026. THEY STATED THAT THE DISPOSABLE LEADS WERE PERSISTENTLY ALARMING FOR VTACH, AND INTERMITTENTLY APPEARED TO BE A TRUE VTACH ON THE MONITOR. ACCOUNT REPOSITIONED THE LEADS WITH NO CHANGE. ON ACQUIRING A FORMAL EKG, THE PATIENT WAS IN CLEAR NORMAL SINUS RHYTHM. AFTER REPLACING THE ENTIRE LEAD SET (INCLUDING THE TRUNK CORD) THE RHYTHM ON THE MONITOR MATCHED THE NSR ON THE EKG. ECG READING IS ATTACHED. PER THE CUSTOMER ON (B)(6) 2026 THE PATIENT EXPERIENCED UNDUE ANXIETY AND THIS PULLED THE ENTIRE MEDICAL TEAM AWAY FROM OTHER ROUTINE CARE.

  Patient problems: Anxiety

  MAUDE report 25045217 ↗
• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE NURSE NOTICED THAT THE LEADS WERE SHOWING A NORMAL SINUS RHYTHM (NSR) RHYTHM, BUT THE MONITOR WAS READING IT AS ASYSTOLE. SHE TRIED REPOSITIONING THE LEADS AND NOTHING WORKED. SHE REPLACED THE LEADS WITH A NEW SET AND THEY WERE FINE. ACCORDING TO THE CUSTOMER, THE ONLY THING THE REGISTERED NURSE (RN) CAN THINK OF WAS THAT SHE WAS GIVING A BED BATH WITH THE MEDLINE READY BATH WIPES JUST PRIOR TO THIS HAPPENING. BUT THE LEADS WERE NOT OVERLY SATURATED WITH FLUID. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576057 ↗