RHYTHMIA HDx™ M004RH40100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729948407), received between Aug 29, 2022 and Oct 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE WORKSTATION FAILED TO BOOT. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. DURING PREPARATION FOR A PROCEDURE, A RHYTHMIA HDX WORKSTATION PC WAS SELECTED FOR USE. THE WORKSTATION FAILED TO BOOT. AFTER MULTIPLE RESTART ATTEMPTS, THE SYSTEM REMAINED NON-FUNCTIONAL, EVEN AFTER WAITING APPROXIMATELY 15 MINUTES. ISSUE WAS UNABLE TO BE RESOLVED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND IT'S UNKNOWN IF PATIENT SEDATION WAS PERFORMED. EQUIPMENT WILL BE REPLACED BY A NEWER VERSION. THE EQUIPMENT WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316616 ↗
• MalfunctionAug 29, 2022Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE WITH AN INTELLANAV STABLEPOINT CATHETER, AFTER A FEW MAPS THE RHTYTHMIA WORKSTATION WAS LAGGING, THE SCREEN WAS FREEZING. CASES WERE DELETED IN ORDER TO FREE SOME SPACE, WITHOUT SUCCESS. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT COMPLICATIONS. THE SYSTEM IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310525 ↗