RHYTHMIA HDx™ M004RH20020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729972679), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJun 14, 2024Material Integrity Problem; Material Integrity Problem

  THE RHYTHMIA MAPPING SYSTEM WAS SELECTED FOR USE. IT WAS REPORTED THAT THE LOCALIZATION GENERATOR WAS NOT TRANSMITTING DATA TO THE SIGNAL STATION. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATION WAS REPORTED AND IT IS UNKNOWN IF PATIENT WAS SEDATED AT THE TIME OF PROCEDURE CANCELLATION. THE SYSTEM WILL NOT BE RETURNED AS ONSITE FIELD SERVICE WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT SEDATED AT THE TIME OF PROCEDURE CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537862 ↗