RHYTHMIA HDx™ M004RBINSTALL2EN0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729938682), received between Oct 28, 2020 and Nov 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Operating System 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 18, 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.

• MalfunctionNov 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE RHYTHMIA MAGNET WAS BROKEN, AND THE PROCEDURE WAS CANCELLED. DURING A REDO CRYOABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF), A RHYTHMIA HDX WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE RHYTHMIA MAGNET WAS NOT FUNCTIONING. AS A RESULT, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE ISSUE OCCURRED. THERE WERE NO PATIENT COMPLICATIONS. ONSITE SERVICE HAS BEEN REQUESTED; IT WAS IDENTIFIED THAT THERE WAS AN ISSUE WITH THE LOCALIZATION GENERATOR AND CABLE. IT IS UNKNOWN IF THE DEVICE OR ANY COMPONENTS WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20710931 ↗
• MalfunctionJun 6, 2023Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE SYSTEM WAS LAGGING DURING THE SECOND CASE OF THE DAY. THE MOUSE CURSOR WAS SHOWING THE SPINNING CIRCLE CONSTANTLY AND INPUTTING ANY INFORMATION OR DATA WOULD TAKE SEVERAL SECONDS TO INPUT AND SHOW ON THE SCREEN. PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. PATIENT SEDATION STATUS IS UNKNOWN. CONSOLE IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075555 ↗
• MalfunctionOct 28, 2020Device Displays Incorrect Message; Data Problem; Device Displays Incorrect Message; Data Problem

  IT WAS REPORTED THAT DUE TO A DEVICE ISSUE THE PROCEDURE WAS CANCELLED. DURING A PROCEDURE AN BACKPATCH WAS SELECTED FOR USE. WHEN THE PATIENT WAS REMOVED FROM THE PROCEDURE TABLE THERE WAS NO TRACKING OF THE CATHETER ON THE RHYTHMIA SYSTEM. THE RHYTHMIA MAPPING SPECIALIST (RMS) REBOOTED THE WORKSTATION AND SIGNAL STATION WHICH DID NOT RESOLVE THE ISSUE. REPLACING THE CABLE AND THE CATHETER ALSO DID NOT RESOLVE THE ISSUE. THEREFORE THE ABLATION PORTION OF THE PROCEDURE WAS CANCELLED AND THE PHYSICIAN PROCEEDED TO IMPLANT THE CARDIAC RESYNCHRONIZATION THERAPY DEVICE IN THE PATIENT SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. ADDITIONAL INFORMATION REVEALED THAT AFTER THE CASE THE RMS REPLACED THE BACKPATCH AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747612 ↗