Kendall 33114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884527021738), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 16, 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.

• MalfunctionJul 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CVICU NURSE STATED THAT THEY ARE HAVING ISSUES WITH TRACINGS (ARTIFACT AND ASYSTOLE) WHEN THE LEAD SET IS USED WITH THEIR EXTERNAL PACING WIRES ON PATIENTS POST CABG. THEY ARE REMOVING KDL FROM THE OPERATING ROOM AND PLACING THEIR REUSABLES FROM PHILLIPS WITHOUT TRACING ISSUES. NO INJURIES HAVE OCCURRED. PER ADDITIONAL INFORMATION PROVIDED, THIS ISSUE HAPPENED WITH ALL OF THE NURSE'S PATIENTS WITH EXTERNAL PACER WIRES THAT CAME FROM THE OR WITH KDL. THEY ALWAYS SWITCHED BACK TO REUSABLE CABLE/LEADSETS WITH EXTERNAL PACER WIRES AND THE ISSUE WAS RESOLVED. NO FURTHER INFORMATION IS AVAILABLE ABOUT EACH SPECIFIC INCIDENT OR THE EXACT NUMBER OF PATIENTS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957232 ↗