Reveal LINQ™ LNQ11 (UDI 00763000562625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 431 adverse event reports that list this exact device (DI 00763000562625), received between Dec 16, 2021 and Sep 30, 2026 — classified as 60 injuries, 371 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (155 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 25 most recent of 431 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing on Bradycardia and Atrial Tachycardia (AT)/ Atrial Fibrillation (AF) episodes. It was noted that the remote monitoring report failed to generate and was not received for review. 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 50944062 ↗
• MalfunctionSep 24, 2026Over-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced oversensing. It was further reported that a transmission was not received for review. 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 50882902 ↗
• MalfunctionSep 18, 2026Over-Sensing; Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing and oversensing. It was further reported Remote Monitoring Network report did not generate. 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 50818119 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem

  It was reported that the Implantable Cardiac Monitor (ICM) was paired to the remote monitor prior to Implant resulting in the Reason for Monitoring displaying? marks. It was further noted that the last connection showed invalid parameters. 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 50817048 ↗
• MalfunctionSep 15, 2026Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing on a tachycardia episode. It was noted that there were X's on the Portable Document Format (PDF) pages of the remote monitoring network reports. 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 50772931 ↗
• MalfunctionSep 9, 2026Communication or Transmission Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced connectivity issues with the remote monitor. This resulted in no successful transmissions to the Remote monitoring network for a short period of time. The ICM remains in use. It was also reported that the implanted device and monitor had not successfully communicated since (b)(6) 2026. The communication between the device and the monitor could not be established, resulting in unsuccessful wireless transmissions. No troubleshooting indicated. No patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688656 ↗
• MalfunctionSep 7, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50648818 ↗
• MalfunctionSep 2, 2026Over-Sensing; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562767 ↗
• MalfunctionSep 2, 2026Over-Sensing; Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced slight undersensing and oversensing. It was noted that there were invalid histograms observed on the Remote Monitoring Report. 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 50561853 ↗
• InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50559771 ↗
• MalfunctionSep 1, 2026Over-Sensing; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543729 ↗
• MalfunctionSep 1, 2026Under-Sensing; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542920 ↗
• MalfunctionAug 28, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493360 ↗
• MalfunctionAug 27, 2026Over-Sensing; Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) exhibited oversensing and 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 50470893 ↗
• MalfunctionAug 26, 2026Over-Sensing; Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) exhibited oversensing and 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 50453869 ↗
• MalfunctionAug 14, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251824 ↗
• MalfunctionJul 28, 2026Unable to Obtain Readings

  It was reported that the Implantable Cardiac Monitor (ICM) had no electrocardiogram (ECG)s for pause episodes in the remote monitoring Episode list. 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 50049807 ↗
• MalfunctionJul 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25836840 ↗
• MalfunctionJul 9, 2026Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. IT WAS NOTED THAT THE DEVICE CLOCK HAD RESET. 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 25761840 ↗
• MalfunctionJun 26, 2026Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE DIAGNOSTIC MOBILE PROGRAMMER APPLICATION DISPLAYED ERROR MESSAGES, INDICATING SEVERAL ISSUES WITH THE IMPLANTABLE CARDIAC MONITOR (ICM), ONE BEING A ELECTRICAL RESET AND THE OTHER ERROR INDICATED THAT THE ICM EXPERIENCED A TELEMETRY ISSUE. 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 25633956 ↗
• MalfunctionJun 22, 2026Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. 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 25574689 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED AN INFLAMATORY REACTION WHICH INCLUDED REDNESS AND A HOT FEELING AROUND THE IMPLANT SITE. IT WAS NOTED THAT THERE WAS AN AREA OF PIMPLY SKIN AND PUS THAT HAD SPREAD FROM THE LEFT TO THE RIGHT ACROSS THE CHEST AREA. THE ICM REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Purulent Discharge

  MAUDE report 25543586 ↗
• MalfunctionJun 16, 2026Communication or Transmission Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIAC MONITOR WAS NOT FUNCTIONING PROPERLY, WITH ALLEGATIONS THAT THE CARDIAC MONITOR DID NOT CONSISTENTLY DETECT THE PATIENT¿S HEART SIGNAL, HAD TROUBLE TRANSMITTING DATA, AND PROVIDED NO TELEMETRY. IT WAS FURTHER REPORTED THAT A REPLACEMENT DEVICE HAD BEEN RECEIVED BUT THE SAME ISSUES PERSISTED, INCLUDING THE MONITOR NOT CONSISTENTLY DETECTING THE LOOP RECORDER. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING CHECKING THE MONITOR¿S CONNECTION, REPOSITIONING THE DEVICE, POWER CYCLING THE MONITOR, AND CHECKING FOR INTERFERENCE FROM OTHER ELECTRONIC DEVICES. THE LAST TRANSMISSION WAS REPORTED TO HAVE BEEN SENT AUTOMATICALLY TWO DAYS PRIOR, BUT THE MONITOR CONTINUED TO HAVE TROUBLE DETECTING THE LOOP RECORDER. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR DID NOT HAVE ANY SUCCESSFUL WIRELESS TRANSMISSIONS SINCE THE DATE OF CALL. THE ICM REMAINS IN THE PA TIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515847 ↗
• MalfunctionJun 11, 2026Failure to Interrogate

  IT WAS REPORTED THAT A 'NO DEVICE FOUND' MESSAGE WAS DISPLAYED DURING A REMOTE MONITORING MOBILE APPLICATION INTERROGATION. IT WAS NOTED THAT THE APPLICATION WAS UNABLE TO LOCATE THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REBOOTING THE HOST TABLET, RECONNECTING TO WIRELESS FIDELITY, VERIFYING THAT THE PATIENT CONNECTOR WAS CHARGED, AND REATTEMPTING THE INTERROGATION. IT WAS FURTHER NOTED THAT THE HOST TABLET WAS UNABLE TO DETECT THE ICM EVEN WHEN THE PATIENT CONNECTOR WAS POSITIONED DIRECTLY OVER THE DEVICE AND REPOSITIONED MULTIPLE TIMES. 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 25470542 ↗
• MalfunctionJun 10, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD  MIGRATED TO THE FAR SIDE ON THE PATIENT. 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 25457876 ↗