Wi-Box™ AO TransmitterRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734054140), received between Mar 4, 2021 and Apr 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Communication or Transmission Problem

  DURING A PROCEDURE, AN AO READING WAS UNABLE TO BE OBTAINED. MULTIPLE CABLES WERE EXCHANGED WITH NO RESOLUTION. THE PROCEDURE WAS ABANDONED BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821068 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  DURING A DIAGNOSTIC PROCEDURE, THERE WAS AO DRIFT. THE ISSUE WAS FOUND TO BE CAUSED BY THE WI-BOX AND ADAPTER AND MONITOR CABLES. THE PROCEDURE WAS ABANDONED, BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709100 ↗
• MalfunctionMar 17, 2026Communication or Transmission Problem

  DURING THE PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOT POSSIBLE TO GET AN AO PRESSURE. THE CORRECT ROOM WAS SELECTED, AND THE CORRECT WI BOX SN WAS POPULATED. THE PROCEDURE WAS CANCELLED AS A RESULT. THE PATIENT'S TREATMENT WAS MOVED TO MEDICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619875 ↗
• MalfunctionMar 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A CFR/IMR PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. THE NON-ABBOTT (COROVENTIS) SYSTEM DID NOT DETECT AN AO SIGNAL FROM THE TRANSDUCER. THE PRESSURE WIRE WAS EXCHANGED BUT THE ISSUE WAS NOT RESOLVED. THE NON-ABBOTT (COROVENTIS) SYSTEM WAS WORKING AS EXPECTED AND THE ISSUE WAS DEEMED TO BE DUE TO THE WI-BOX. THE PROCEDURE WAS CANCELLED DUE TO NO AO SIGNAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561240 ↗
• MalfunctionMar 28, 2023Power Problem; Power Problem

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, PRESSURE WAS LOST RESULTING IN CANCELLATION OF THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE ISSUE UNSUCCESSFULLY. THE ENTIRE SYSTEM WAS REBOOTED WHICH CONFIRMED THE WI-BOX CRASHED RESULTING IN THE PRESSURES NOT BEING SEEN ON THE MACLAB. THE PROCEDURE WAS THEN CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631329 ↗
• MalfunctionMar 4, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN RFR PHYSIOLOGY STUDY, WHEN TRYING TO ACQUIRE AO PRESSURE, THE WI-BOX AO TRANSMITTER WAS UNABLE TO ESTABLISH CONNECTION WITH THE PRESSUREWIRE X. THE RED LIGHT CAME ON (NOT READY INDICATOR) ON THE WI-BOX AND POWERED OFF. ALL THE CONNECTIONS TO THE WI-BOX WERE CHECKED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABORTED DUE TO THIS ISSUE. THE WI-BOX WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11410952 ↗