RHYTHMIA HDx™ M004RH10200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729938712), received between Sep 1, 2021 and Oct 1, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Data Problem” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Power Conditioning Problem; Power Conditioning Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. THE RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT A MAP WAS CREATED USING THE ORION CATHETER, FOLLOWED BY AN ABLATION USING THE FARAWAVE SYSTEM. UPON RETURNING TO THE ORION SYSTEM, THERE WAS SATURATED NOISE ON THE 12 LEAD AND THE REFERENCE AND RHYTHMIA SYSTEMS. THEY TRIED RESTARTING EVERYTHING, BUT THE ISSUE PERSISTED AS THE REFERENCE WAS DISCONNECTED. THE ORION WAS FLASHING CONSTANTLY, AND THEY WERE UNABLE TO TRACK THE BASKET. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ISSUE. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT A WORK ORDER WAS PERFORMED ONSITE. DEFECTIVE SIGNAL STATION WAS REPLACED WITH NEW SIGNAL STATION AND NEW SYSTEM WAS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343602 ↗
• MalfunctionJul 17, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A SIGNAL STATION WAS SELECTED FOR USE. DURING MAPPING, ORION WAS BLINKING FREQUENTLY. CONNECTION BOX AND CABLE WERE CONNECTED AGAIN, SIS WAS REBOOTED, AND CONSIDERING EXTERNAL FACTORS, BIS AND ESOPHAGEAL TEMPERATURE MONITOR POSITION WERE CHANGED, AND IT WAS DISCONNECTED, AND IT IMPROVED TEMPORARILY, BUT THE SAME SYMPTOMS OCCURRED AGAIN. PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS ISSUE. SHIPMENT FOR SIS REPLACEMENT WAS REQUESTED. MOREOVER, THE PHYSICIAN POINTED OUT THAT IT COULD NOT BE USED UNLESS EQUIPMENT INSPECTION AND SITE INVESTIGATION ARE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762799 ↗
• MalfunctionJun 18, 2024Device Displays Incorrect Message; Data Problem; Device Displays Incorrect Message; Data Problem

  THIS COMPLAINT IS BEING REPORTED FOR A PROCEDURE CANCELLATION WITH PATIENT SEDATION UNKNOWN. IT WAS REPORTED THAT DURING A PROCEDURE A SIGNAL STATION 2 WAS SELECTED FOR USE. THE ERRORS 1105-2, 1113-2 AND 1318 WERE DISPLAYED. THE CONDITION WAS NOT ABLE TO BE SOLVED, SO THE PROCEDURE HAD TO BE CANCELLED. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE PATIENT WAS ALREADY SEDATED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555661 ↗
• MalfunctionJan 12, 2024Defective Device; Defective Device

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PROCEDURE A RHYTHMIA HDX SIGNAL STATION 2 WAS SELECTED FOR USE. IT WAS FOUND THAT THE INCOMING AND OUTGOING SIGNALS WERE NOT DISPLAYED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503957 ↗
• MalfunctionMay 19, 2022Data Problem; Data Problem

  POST ABLATION PROCEDURE A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE PHYSICIAN NOTICED INTERFERENCE AFTER ABLATION WAS COMPLETED, AND THE PROCEDURE WAS ULTIMATELY NOT COMPLETED DUE TO THE INCIDENT. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435871 ↗
• MalfunctionOct 18, 2021Power Conditioning Problem; Device Displays Incorrect Message; Power Conditioning Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE DIAGNOSTIC PORTION OF A RHYTHMIA MAPPING PROCEDURE, THE EGM AND ECG TRACINGS APPEARED NORMAL. HOWEVER, WHEN RADIOFREQUENCY (RF) ENERGY WAS DELIVERED FROM A STABLEPOINT CATHETER THROUGH THE MAESTRO RF GENERATOR, EXCESSIVE NOISE WAS OBSERVED ON MULTIPLE CHANNELS ON BOTH THE RECORDING SYSTEM AND MAPPING SYSTEM. NOISE OCCURRED AT THE FIRST RF ATTEMPT. SUBSEQUENT TESTS AFTER THE DIFFERENT TROUBLESHOOTING STEPS DISPLAYED SIMILAR NOISE. NOISE DID NOT APPEAR TO BE ASSOCIATED WITH THE ARTICULATION OF THE CATHETER, ONLY DURING RF DELIVERY. REPLACING THE CATHETER CABLE, THE CATHETER, AND REPLACING THE STABLEPOINT MAESTRO CONNECTION BOX DID NOT RESOLVE THE ISSUE. ADDITIONALLY, REBOOTING THE SIS DID NOT RESOLVE THE ISSUE. THE RHYTHMIA MAPPING SPECIALIST (RMS) STATED THAT THE LOCAL IMPEDANCE (DIRECT SENSE) AND GLOBAL IMPEDANCE SEEMED EXCESSIVELY HIGH (~220 OHMS ON MAESTRO). THE DIRECT CONNECT CABLES WERE SECURED WITHOUT ISSUE. REPLACING THE DISPERSIVE INDIFFERENT PATCH (DIP) TO THE MAESTRO AND ROUTING IT AWAY FROM THE ECG CABLE DID NOT RESOLVE THE ISSUE. THERE WAS NO REPLACEMENT MAESTRO OR MAESTRO POD AVAILABLE. THE PROCEDURE WAS CANCELLED, AND NO PATIENT COMPLICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647981 ↗
• MalfunctionSep 1, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  DURING PREPARATION FOR A PROCEDURE IT WAS REPORTED THAT THE DEVICE ARRHYTHMIA MAPPING SYSTEM OVERHEATED AND CRASHED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE EVENT OCCURRED DURING PREPARATION. HOWEVER, THE SEDATION STATUS OF THE PATIENT WAS NOT SPECIFIED. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407719 ↗