REVEAL® XT 9529 (UDI 00643169494893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00643169494893), received between Jun 8, 2017 and Apr 24, 2023 — classified as 1 injury, 50 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (28 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT COLLECTING INFORMATION FROM THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE. THE ICM HAD NO TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN AND STILL NOT GETTING THE PROGRESS BAR. THE CALLER WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE AND 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 16794804 ↗
• MalfunctionApr 7, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). IT WAS ALSO RE PORTED THAT AN ERROR CODE OF 7332 APPEARED INDICATING THE CONNECTION TO LOOK UP THE AFFILIATED DEVICE IN THE REMOTE MONITORING NETWORK WAS UNSUCCESSFUL OR TIMED OUT. TROUBLESHOOTING STEPS WERE EXHAUSTED AND STILL PROGRESS BAR WOULD NOT START. THE PATIENT WAS REFER RED TO THE CLINIC AND TO TAKE THE MONITOR TO THE APPOINTMENT. THE MONITOR REMAINS IN USE. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700184 ↗
• MalfunctionNov 23, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850537 ↗
• MalfunctionAug 31, 2021Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING ON ASYSTOLE AND BRADYCARDIA EPISODES. IT WAS FURTHER REPORTED THAT THE DEVICE EXPERIENCED OVERSENSING NOISE ON EPISODES. 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 12390597 ↗
• MalfunctionMay 27, 2021Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FALSE PAUSE EPISODES DUE TO UNDERSENSING. IT WAS FURTHER REPORTED THAT THE ICM DETECTED FALSE VENTRICULAR TACHYCARDIA (VT) DUE TO OVERSENSING. THE ICM 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 11892837 ↗
• MalfunctionMay 7, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING R-WAVES/PREMATURE VENTRICULAR CONTRACTIONS (PVC) WHICH RESULTED IN FALSE PAUSE AND BRADYCARDIA EPISODES. THE ICM 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 11788908 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFECTION AND THE SITE WOULD NOT HEAL PROPERLY. THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 11409337 ↗
• MalfunctionMar 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD NO TELEMETRY. THE ICM 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 11391641 ↗
• MalfunctionNov 25, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING. THE ICM 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 10904411 ↗
• MalfunctionJun 23, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY AS THE READER WAS REPOSITIONED MULTIPLE TIMES. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183008 ↗
• MalfunctionJun 15, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FASCICULAR VENTRICULAR TACHYCARDIA (FVT) DUE TO OVERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152403 ↗
• MalfunctionMay 20, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED T-WAVE OVERSENSING (TWOS). THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073867 ↗
• MalfunctionFeb 28, 2020Over-Sensing; Over-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9768267 ↗
• MalfunctionFeb 10, 2020Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687328 ↗
• MalfunctionSep 20, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A PAUSE EPISODE THAT LOOKS TO BE LOSS OF CONTACT. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9096623 ↗
• MalfunctionSep 18, 2019Under-Sensing; Device Sensing Problem; Under-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A FALSE PAUSE EPISODE DUE TO UNDERSENSING OF THE QRS COMPLEX. IT WAS FURTHER REPORTED THAT TACHYCARDIA EPISODES DO NOT APPEAR TO BE VENTRICULAR TACHYCARDIA (VT).THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9080950 ↗
• MalfunctionSep 11, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED A PAUSE EPISODE DUE TO UNDERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8988143 ↗
• MalfunctionAug 22, 2019Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED DIMINISHED R WAVES AND LOSS OF CONTACT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8920619 ↗
• MalfunctionAug 15, 2019Under-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896191 ↗
• MalfunctionJun 28, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FALSE PAUSE DUE TO UNDERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743105 ↗
• MalfunctionMay 28, 2019Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) BATTERY DEPLETED PREMATURELY, AND COULD NOT BE INTERROGATED. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645358 ↗
• MalfunctionApr 17, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED OVERSENSING ARTIFACT. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522044 ↗
• MalfunctionApr 12, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED R-WAVE UNDERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8508270 ↗
• MalfunctionApr 10, 2019Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8499662 ↗
• MalfunctionApr 5, 2019Under-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486876 ↗