Reveal LINQ™, Reveal® LNQ11 (UDI 00643169323575)Recalls & reported problems

Summary

The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 00643169323575), received between Dec 10, 2014 and Aug 12, 2019 — classified as 1 injury, 306 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (135 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 307 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE REACHED END OF SERVICE (EOS) 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 8882321 ↗
• MalfunctionJul 10, 2019Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) COULD NOT BE READ BY THE PROGRAMMER. IT WAS FURTHER REPORTED THAT THE ICM BATTERY IS DEAD. 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 8774783 ↗
• MalfunctionJul 2, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) BATTERY IS ALREADY DEAD. THE ICM 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 8753685 ↗
• MalfunctionJun 24, 2019Battery Problem; Battery Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THE ICM BATTERY FAILED. THE ICM 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 8726160 ↗
• MalfunctionJan 18, 2019Failure to Interrogate; Failure to Interrogate

  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 8260412 ↗
• InjuryJan 18, 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 8260145 ↗
• MalfunctionDec 3, 2018Failure to Interrogate; Failure to Interrogate

  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 8123941 ↗
• MalfunctionNov 28, 2018Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY WITH THE REMOTE MONITOR. 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 8109771 ↗
• MalfunctionNov 20, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT HAVE TELEMETRY WITH THE REMOTE MONITOR. 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 8088590 ↗
• MalfunctionNov 13, 2018Failure to Interrogate; Failure to Interrogate

  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 8064195 ↗
• MalfunctionOct 31, 2018Incorrect 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 INCORRECT COUNTERS AND THERE WAS NO ELECTROCARDIOGRAM (ECG) SHOWING ON THE REPORT. 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 8023178 ↗
• MalfunctionOct 24, 2018Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000567 ↗
• MalfunctionOct 24, 2018Battery Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. 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 7998611 ↗
• MalfunctionOct 18, 2018Communication 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 7978020 ↗
• MalfunctionOct 18, 2018Incorrect 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 HAD REACHED DEVICE MAX AND THERE WAS NO CURRENT ELECTROCARDIOGRAM (ECG). IT WAS NOTED THAT THE ICM HAD REACHED END OF SERVICE (EOS). 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 7977120 ↗
• MalfunctionOct 15, 2018Communication 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 7964736 ↗
• MalfunctionOct 12, 2018Communication 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 7960758 ↗
• MalfunctionOct 4, 2018Battery Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. IT WAS FURTHER REPORTED 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 7933100 ↗
• MalfunctionSep 20, 2018Communication or Transmission Problem; Reset Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THEY FELT THE ICM WAS "DEFECTIVE". IT WAS FURTHER REPORTED THAT THE ICM WAS "SHORTING OUT" AND READINGS COULD NOT BE TAKEN FROM THE DEVICE. THE ICM 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 7892710 ↗
• MalfunctionSep 17, 2018Under-Sensing; Battery Problem; Under-Sensing; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING. IT WAS FURTHER REPORTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE ICM WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880948 ↗
• MalfunctionSep 14, 2018Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. 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 7876630 ↗
• MalfunctionSep 13, 2018Unable to Obtain Readings; Communication or Transmission Problem; Unable to Obtain Readings; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS NEVER TURNED ON AND THEY DON'T HAVE IT CONNECTED. 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 7872033 ↗
• MalfunctionSep 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT IS NOT USING THEIR ICM AND IT'S NOT FUNCTIONING ANYMORE. 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 7842315 ↗
• MalfunctionAug 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) BATTERY HAD DIED AND IT WAS "NOT FUNCTIONING". 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 7826313 ↗
• MalfunctionAug 24, 2018Communication 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 7812200 ↗

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.