REVEAL® XT 9529 (UDI 00643169093881)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169093881), received between Jan 22, 2021 and May 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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. How this data works · Data updated Oct 13, 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 26, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT ACQUIRE A SIGNAL, THE SIGNAL APPEARED LIKE NOISE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884121 ↗
• MalfunctionMay 21, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ON THE DAY OF THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR (ICM) BASELINE WAS GOING FROM "RAIL TO RAIL", AND IT WAS SUSPECTED THE ICM WAS NOT SENSING PROPERLY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863647 ↗
• MalfunctionJan 22, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED VENTRICULAR OVERSENSING AND VENTRICULAR UNDERSENSING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213939 ↗