Reveal LINQ™ LNQ11 (UDI 00763000562632)Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00763000562632), received between Oct 11, 2021 and Sep 28, 2026 — classified as 20 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (74 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 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914723 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardiac Monitor (ICM) patient experienced an infection. The patient was prescribed antibiotics however this did not clear the infection. The ICM was removed. It was further noted that the patient had an allergy to surgical glues and several antibiotics. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50911495 ↗
• MalfunctionSep 24, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882881 ↗
• MalfunctionAug 25, 2026Over-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced intermittent oversensing. It was noted that the remote monitoring network transmission had not exported 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 50431975 ↗
• MalfunctionJul 30, 2026Migration or Expulsion of Device

  Patient problems: Discomfort

  MAUDE report 50084026 ↗
• MalfunctionJul 13, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25793822 ↗
• MalfunctionJun 29, 2026Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) COULD NOT BE CONNECTED TO THE BEDSIDE MONITOR. MULTIPLE ATTEMPTS WERE MADE WITH A SECOND MONITOR BUT WERE UNSUCCESSFUL. IT WAS FURTHER REPORTED THERE WAS AN ICM BATTERY MALFUNCTION. 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 25659936 ↗
• MalfunctionJun 24, 2026Reset Problem; Data Problem

  IT WAS REPORTED THAT AFTER A MANUAL TRANSMISSION, THE REMOTE MONITOR SCREEN DISPLAYED AN INCORRECT DATE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET DUE TO BATTERY SUPPLY LOW. THIS CORRUPTED THE DEVICE CLOCK. 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 25606632 ↗
• MalfunctionMay 26, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT DISPLAY ELECTROGRAMS (EGM) FOR TWO ATRIAL FIBRILLATION (AF) EPISODES.. IT WAS NOTED THAT THERE WERE NO CURRENT EPISODES SHOWING IN THE 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 25277340 ↗
• MalfunctionApr 24, 2026Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A FALSE PAUSE EPISODE DUE TO UNDER SENSING. IT WAS NOTED THAT THE REMOTE MONITORING NETWORK TRANSMISSION WAS NOT RECEIVED AND THE PORTABLE DOCUMENT FORMAT (PDF) REPORTS WERE NOT GENERATING. 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 24978379 ↗
• MalfunctionApr 15, 2026Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED FALSE PAUSE EPISODES DUE TO UNDER SENSING. IT WAS NOTED THAT THE REMOTE MONITORING NETWORK TRANSMISSIONS WERE 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 24881559 ↗
• MalfunctionApr 13, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN ATTEMPTED MANUAL TRANSMISSION FOR AN IMPLANTABLE CARDIAC MONITOR (ICM) USING THE MYCARELINK REMOTE MONITOR NO TELEMETRY WAS ESTABLISHED. TROUBLESHOOTING INCLUDED POWER CYCLING THE MONITOR, CHECKING FOR INTERFERENCE, AND ATTEMPTING AN ADDITIONAL TRANSMISSION; TELEMETRY WAS STILL NOT RECEIVED. THE PATIENT WAS REFERRED FOR AN IN-OFFICE DEVICE CHECK USING THE PATIENT¿S MONITOR. 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 24858628 ↗
• MalfunctionMar 24, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT INVALID EPISODE(S) WERE OBSERVED ON THE LINQ IMPLANTABLE CARDIAC MONITOR DURING REMOTE MONITORING VIA CARELINK EXPRESS TRANSMISSION. 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 24674221 ↗
• MalfunctionMar 18, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE MONITOR SHOWED AS DISCONNECTED ON THE NETWORK, AND THE PREVIOUS MONITOR WAS ALSO UNABLE TO READ THE LOOP RECORDER. AFTER A REPLACEMENT MONITOR WAS PROVIDED, THE SAME ISSUE PERSISTED, WITH THE DEVICE NOT TRANSMITTING DATA AND THE PROGRESS BAR NOT FILLING. ATTEMPTS TO TRANSMIT RESULTED IN THE GREEN LIGHT NEVER APPEARING, AND THE PATIENT WAS NOT CONNECTED TO THE DEVICE. TROUBLESHOOTING STEPS INCLUDED REBOOTING THE MONITOR AND CONFIRMING A GOOD SIGNAL, ATTEMPTING TRANSMISSION, USING A DRY WASHCLOTH TO RE-ATTEMPT, REMOVING ELECTROMAGNETIC INTERFERENCE DEVICES, AND CHECKING BATTERY STATUS, WHICH WAS CONFIRMED TO BE OK. AFTER TROUBLESHOOTING WAS EXHAUSTED, THE PATIENT WAS REFERRED TO THE CLINIC. 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 24626354 ↗
• MalfunctionMar 12, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THE REMOTE MONITORING NETWORK TRANSMISSION REPORT DISPLAYED AS 'NO DATA AVAILABLE' FOR PRESENTING ELECTROCARDIOGRAM (ECG) ON BOTH LAST DATA SEND AND SUMMARY REPORTS FROM FEW MONTHS. A TICKET WAS CREATED. ADVISED PATIENT TO SEND A MANUAL TRANSMISSION. IT WAS FURTHER NOTED THAT THE ISSUE WAS RELATED TO THE IMPLANTABLE CARDIAC MONITOR (ICM) MOST LIKELY MALFUNCTIONING AS NO MARKERS HAD BEEN COLLECTED BY THE DEVICE. THE PATIENT CONFIRMED THAT THEY WORK NEAR ELECTRONIC MACHINERY. THE ICM WAS LATER REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578211 ↗
• MalfunctionMar 12, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIAC MONITOR EXPERIENCED A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH MYCARELINK. THERE WAS NO ERROR DISPLAYED ON THE MONITOR, BUT THE ABSENCE OF A GREEN BAR INDICATED A LACK OF CONNECTION OR TELEMETRY. TROUBLESHOOTING STEPS WERE PERFORMED. THE PATIENT WAS REFERRED TO THE CLINIC FOR FURTHER ASSISTANCE. 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 24577699 ↗
• MalfunctionMar 11, 2026Reset Problem

  IT WAS REPORTED THAT AN ELECTRICAL RESET WAS ALLEGED FOR THE IMPLANTABLE CARDIAC MONITOR AND THAT THE PATIENT HAD RECENTLY UNDERGONE AN ABLATION. THE ELECTRICAL RESET WAS CLEARED AND THE DEVICE WAS FUNCTIONING AS PROGRAMMED. THE ICM REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575174 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD ERODED OUT OF THE INCISION SITE BY ONE THIRD OF IT'S LENGTH. IT WAS NOTED THAT THE ICM HAD DETECTED A NINE MINUTE PAUSE. THE ICM HAS BEEN EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24375562 ↗
• MalfunctionFeb 18, 2026Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED INTERMITTENT UNDERSENSING ON TACHYCARDIA EPISODES. IT WAS FURTHER NOTED THAT THE REMOTE MONITORING REPORT CONTAINED INVALID HISTOGRAMS, DID NOT GENERATE AND THAT THE TRANSMISSION HAD NOT BEEN 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 24375034 ↗
• MalfunctionFeb 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH MYCARELINK, AND THERE WAS AN UNSUCCESSFUL DAILY WIRELESS AUDIT. ADDITIONAL ISSUES INCLUDED TELEMETRY NOT WORKING WITH THE DEVICE REPEATEDLY BEEPING, THE PROGRESS BAR STOPPING AND NOT COMPLETING DURING A TRANSMISSION ATTEMPT, AND THE PROGRESS BAR NOT STARTING DURING A SUBSEQUENT ATTEMPT. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE POSITION OF THE READER, POWER CYCLING THE MONITOR, PLACING A DRY WASHCLOTH, VERIFYING THE ABSENCE OF NEARBY ELECTRONICS, AND REPEATING TRANSMISSION ATTEMPTS. THE PROGRESS BAR STARTED TO COMPLETE BUT THEN STOPPED, AND THE READER BEGAN BEEPING; ON A SUBSEQUENT ATTEMPT, THE PROGRESS BAR DID NOT START. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR DID NOT HAVE ANY SUCCESSFUL AUTOMATIC TRANSMISSIONS SINCE THE DATE OF THE CALL. THE PATIENT WAS REFERRED TO A CLINIC. 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 24256219 ↗
• MalfunctionJan 27, 2026Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A FALSE PAUSE DUE TO LOSS OF CONTACT. 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 24189250 ↗
• MalfunctionJan 23, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT FELL OUT OF BED AND THE IMPLANTABLE CARDIAC MONITOR MOVED OUT OF PLACE, INDICATING DEVICE MIGRATION. 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 24160591 ↗
• MalfunctionJan 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH MYCARELINK REMOTE MONITOR. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE READER POSITION, POWER CYCLING THE MONITOR, PLACING THE READER OVER CLOTHES, REMOVING INTERFERENCE, OBSERVING THE PROGRESS BAR FILL AND THEN STOP DURING TELEMETRY. THE PATIENT WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION. 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 24078252 ↗
• MalfunctionDec 4, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT REPORTED A SMALL SHIFT IN THE IMPLANTABLE CARDIAC MONITOR (ICM) PLACEMENT. IT WAS NOTED THAT THE ICM WAS WORKING CORRECTLY AND SOME MOVEMENT CAN BE EXPECTED. 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 23713190 ↗
• MalfunctionDec 3, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED OVERSENSING ON OCCASION. IT WAS NOTED THAT THE REMOTE MONITORING NETWORK TRANSMISSIONS WERE NOT RECEIVED AND THERE WERE INVALID HISTOGRAMS OBSERVED. 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 23702537 ↗