RHYTHMIA HDx™ M004RA6201US0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729966326), received between Dec 14, 2021 and Apr 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P020025, P150005); they may or may not involve this specific model.

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.

• MalfunctionApr 19, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AN UNKNOWN CATHETER WAS INSERTED INTO THE PATIENT AND THE CATHETER TEMPERATURE WAS "ABNORMAL." THE TEMPERATURE WAS AROUND 45 DEGREES CELSIUS. REPLACING THE "BIG END", REINSERTING AND UNPLUGGING THE TAIL WIRE, RESTARTING IT ALL DID NOT WORK. EVEN REPLACING IT WITH A NEW NEGATIVE ELECTRODE DID NOT WORK. ONLY WHEN THE SIGNAL STATION WAS TURNED OFF AND ONLY THE RF INSTRUMENT WAS TURNED ON, WOULD THE TEMPERATURE RETURN TO 35 DEGREES CELSIUS. AFTER REPLACING THE CONNECTION BOX - MAESTRO G2, THEY WERE ABLE TO CONTINUE THE PROCEDURE WITH THE SAME CATHETER. NO PATIENT COMPLICATIONS OCCURRED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143895 ↗
• MalfunctionDec 14, 2021Device Displays Incorrect Message; Material Integrity Problem; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CARDIAC MAPPING AND ABLATION PROCEDURE, AN ERROR OF D07 EXCESSIVE TEMP WAS OBSERVED ON THE MAESTRO SYSTEM. THE METRIQ TUBING WAS SECURED AND NO LEAKS WERE OBSERVED. THE CATHETER AND CABLE WERE EXCHANGED, HOWEVER THE ERROR PERSISTED. THE RHYTHMIA HDX MAESTRO G2 CATHETER CONNECTION BOX WAS NOTED TO BE FRAYED. AND ALSO REPLACED, HOWEVER, THE ERROR WAS NOT RESOLVED. THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020025, P150005. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2019 · Nov 28, 2018 · Open, Classified
  Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, ar
• Z-0202-2019 · Jun 20, 2018 · Open, Classified
  Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,