OPAL HDx™ M004OPLINSTALL2EN0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506055370), received between Nov 11, 2025 and May 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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.

• MalfunctionMay 12, 2026Signal Artifact/Noise

  THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT DURING A PROCEDURE, A OPAL HDX WAS SELECTED FOR USE. THE SYSTEM WAS PRODUCING EXCESSIVE NOISE ON BOTH THE OPAL SYSTEM AND THE RECORDING SYSTEM DURING RF DELIVERY WHEN CONNECTED TO AN INTELLAGEN GENERATOR. THE NOISE WAS ONLY OBSERVED ON THE ECG SIGNAL DURING RF DELIVERY. NO NOISE WAS REPORTED OUTSIDE RF APPLICATION. TWO GROUNDING PATCHES WERE UTILIZED DURING THE PROCEDURE. THERE WERE NO ERROR CODES OR ALARMS REPORTED ON THE OPAL SYSTEM OR THE INTELLAGEN GENERATOR. EPPS RECOMMENDED EVALUATION OF ALL SYSTEM CONNECTIONS AND GROUNDING PATCHES AS PART OF TROUBLESHOOTING. THE PHYSICIAN DECIDED, PARTIALLY BASED ON THE ISSUE WITH NOISE ON THE ECG LEADS WHILE ABLATING TO END THE PROCEDURE EARLY WITHOUT KNOWING IF IT WAS SUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150141 ↗
• MalfunctionNov 18, 2025Device Misassembled During Manufacturing /Shipping; Wrong Label; Device Misassembled During Manufacturing /Shipping; Wrong Label

  IT WAS REPORTED THAT THE ISOLATION TRANSFORMER PACKAGED WITH THE OPAL HDX MAPPING SYSTEM INSTALL BUNDLE WAS MISLABELED AS THE UNITED STATES MODEL BUT WAS ACTUALLY THE EUROPEAN MODEL. THIS WAS AN OUT-OF-BOX FAILURE, SO NO PATIENT WAS INVOLVED. A REPLACEMENT TRANSFORMER WAS SHIPPED TO THE CUSTOMER AND INSTALLED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581092 ↗
• MalfunctionNov 11, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A PROCEDURE AN OPAL HDX MAPPING SYS INSTALL BUNDLE WAS SELECTED FOR USE. HOWEVER, A BADHDR ERROR OCCURRED. THE PHYSICIAN DECIDED TO TERMINATE THE THERAPY EARLY SINCE NO MAPPING NAVIGATION COULD BE PROVIDED FOR THE REQUESTED OPAL CASE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519485 ↗