Reveal LINQ™, Reveal® LNQ11 (UDI 00643169547940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 393 adverse event reports that list this exact device (DI 00643169547940), received between Apr 6, 2017 and Sep 16, 2024 — classified as 1 death, 9 injuries, 383 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (152 reports).

1 other recall cover devices cleared under the same FDA submission (K132649); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 393 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT RECORD THE CHANGES FOR EPISODES. THE ICM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223595 ↗
• MalfunctionJul 30, 2021Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) MAY HAVE REACHED END OF SERVICE (EOS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251697 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THE DEVICE WAS REMOVED DUE TO INFECTION. THE ICM IS NO LONGER IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12098702 ↗
• MalfunctionApr 7, 2021Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED A TACHYCARDIA EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). THE DEVICE 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 11626211 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) CAUSED THE PATIENT TO EXPERIENCE PAIN. THE ICM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 10141871 ↗
• MalfunctionMay 7, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY. 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 10031963 ↗
• MalfunctionMar 30, 2020Battery Problem; Communication or Transmission Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY AT RECOMMENDED REPLACEMENT TIME (RRT). 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 9896554 ↗
• MalfunctionJan 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) BATTERY IS DEAD ALREADY AND NO LONGER WORKING. THE ICM REMAINS IN PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641096 ↗
• MalfunctionJan 16, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY. 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 9595276 ↗
• MalfunctionDec 3, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS BROKEN INTO 3 PIECES IN THE BODY WITH ONE OF THE PIECES BEING IN THE PELVIS. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9400337 ↗
• MalfunctionSep 26, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY. 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 9122014 ↗
• InjurySep 9, 2019Adverse 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. THE ICM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8973785 ↗
• MalfunctionJul 19, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER THAN EXPECTED. 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 8806517 ↗
• MalfunctionJun 24, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NO TELEMETRY. 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 8726617 ↗
• MalfunctionJun 15, 2019Failure to Interrogate; Battery Problem; Reset Problem; Failure to Interrogate; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET AND WAS UNABLE TO BE INTERROGATED. IT WAS NOTED THAT THE BATTERY LIFE WAS DEPLETED. 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 8702215 ↗
• MalfunctionJun 7, 2019Failure to Interrogate; Battery Problem; Reset Problem; Failure to Interrogate; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET AND WAS UNABLE TO BE INTERROGATED. IT WAS NOTED THAT THE BATTERY WAS DEPLETED. 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 8678563 ↗
• MalfunctionMay 8, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS FURTHER NOTED THAT THE ICM WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8591048 ↗
• MalfunctionApr 30, 2019Incorrect Measurement; Unable to Obtain Readings; Battery Problem; Incorrect Measurement; Unable to Obtain Readings; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD INVALID COUNTERS MOST LIKELY DUE TO END OF SERVICE (EOS). 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 8563817 ↗
• MalfunctionApr 19, 2019Data Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A BATTERY PROBLEM. THE ICM IS NO LONGER 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 8530630 ↗
• MalfunctionApr 17, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY. 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 8522388 ↗
• MalfunctionApr 16, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY. 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 8518674 ↗
• MalfunctionApr 11, 2019Incorrect Measurement; Unable to Obtain Readings; Battery Problem; Incorrect Measurement; Unable to Obtain Readings; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) COUNTERS WERE HIGH AND THERE WAS NO SUPPORTING ELECTROCARDIOGRAM (ECG) AVAILABLE. IT WAS NOTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS). 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 8503055 ↗
• MalfunctionApr 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS NOT WORKING. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486279 ↗
• MalfunctionApr 3, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THEY WERE HAVING A PROBLEM WITH THEIR MONITOR BECAUSE IT WAS NOT RECORDING. 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 8477345 ↗
• MalfunctionMar 28, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED OVERSENSING DURING TACHYCARDIA EPISODES. IT WAS NOTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS). 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 8459810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132649. One submission often covers many models, so check the product and lot details in each record.

• Z-1249-2016 · Feb 23, 2016 · Terminated
  Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.