RHYTHMIA HDx™ M004RH1020R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729965879), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Power Conditioning 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.

• MalfunctionNov 9, 2022Power Conditioning Problem; Power Conditioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A RHYTHMIA HDX SIGNAL STATION THEY EXPERIENCED NOISE AND A LACK OF A SIGNAL. THERE WAS NOISE AND THEN NO SIGNAL WHEN THE CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM. THEY CHECKED THE AREA WITH A MAPPING AND DIAGNOSTIC CATHETER, CONFIRMING SIGNALS WERE PRESENT WITH THOSE CATHETERS, AND THEN WITHDREW THE ABLATION CATHETER. THEY CHECKED THE CONNECTIONS, HOWEVER, THEY THE PROBLEM CONTINUED. THEY WERE ULTIMATELY UNABLE TO SOLVE THE PROBLEM. THEY DECIDED TO STOP THE PROCEDURE AND RESCHEDULE IT FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS. IT IS CURRENTLY UNKNOWN IF THE SIGNAL STATION IS GOING TO BE RETAINED BY THE SITE OR RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759435 ↗