Reveal LINQ™ LNQ11 (UDI 00643169845893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 343 adverse event reports that list this exact device (DI 00643169845893), received between Mar 6, 2020 and Jan 15, 2026 — classified as 24 injuries, 319 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (144 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 1, 2021Class IIOpen, Classified

   Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

   Z-2102-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 343 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN REPLACED. IT WAS FURTHER NOTED THAT THE ICM WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078309 ↗
• MalfunctionJan 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED OVERSENSING. IT WAS ALSO NOTED THAT THE ICM HAD REACHED END OF SERVICE (EOS) HAVING BEEN IMPLANTED 47 MONTHS. IT WAS ALSO REPORTED THAT THERE WAS INVALID DATA. IT WAS FURTHER REPORTED THAT REMOTE MONITORING NETWORK REPORT IMPLANT DATE WAS INCORRECT. IT WAS ALSO REPORTED THAT REMOTE MONITORING NETWORK REMOTE DEVICE INTERROGATION DATE CHANGED TO DATE OF IMPLANT INSTEAD OF MOST RECENT FULL 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 23971664 ↗
• MalfunctionDec 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A READER POSITION ISSUE OCCURRED, RESULTING IN NO TELEMETRY WITH THE MYCARELINK DEVICE FOR AN INDIVIDUAL WITH AN IMPLANTABLE CARDIAC MONITOR. THE INDIVIDUAL WANTED TO CHECK IF THEIR NEW HANDSET WAS WORKING. NO SOLUTION WAS AVAILABLE PER PRODUCT LABELING, AND THE INDIVIDUAL WAS REFERRED TO THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765872 ↗
• InjuryDec 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT EXPERIENCED DISCOMFORT AT THE DEVICE SITE. THE PATIENT WAS EXTREMELY SENSITIVE TO THE DISCOMFORT AND EXTRA DOSES OF SEDATION AND LIDOCAINE WERE PROVIDED. PATIENT HAD A HIGH TOLERANCE TO PAIN MEDICATION. THE ICM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 23678076 ↗
• MalfunctionNov 28, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR'S TRANSMISSION WAS SENT, BUT THE MONITOR REPEATEDLY PROMPTED TO PLACE THE READER ON THE IMPLANTABLE CARDIAC MONITOR (ICM); MONITOR STILL DID NOT PERFORM THE READING. THE IMPLANT HAD BEEN PLACED OVER FOUR AND A HALF YEARS AGO. THE PATIENT WAS EDUCATED TO CONTACT THEIR CLINIC AND WAS TRANSFERRED TO DIAGNOSTICS FOR FURTHER INFORMATION ABOUT THE ICM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669801 ↗
• MalfunctionOct 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS NO CONNECTION WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309142 ↗
• MalfunctionSep 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN AND THE PATIENT WAS ADVISED TO CHECK THE DEVICE WITH THE CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931888 ↗
• MalfunctionAug 1, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED OVERSENSING. THE DEVICE IS NOW AT END OF SERVICE (EOS). 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 22685280 ↗
• MalfunctionJul 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MYCARELINK MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM), RESULTING IN A TELEMETRY FAILURE. THE MONITOR HAD BEEN DISCONNECTED SINCE OCTOBER 2024. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE MONITOR, PLACING A DRY WASHCLOTH BETWEEN THE READER AND THE IMPLANT, AND REMOVING ANY INTERFERENCE WITHIN SIX FEET, BUT THE SAME PROBLEMS PERSISTED AND THE GREEN PROGRESS BAR WAS NOT VISIBLE. THE PATIENT WAS REFERRED TO THE CLINIC. 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 22673455 ↗
• MalfunctionJul 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD UNSUCCESSFUL DAILY WIRELESS AUDIT (DWA). IT WAS ALSO REPORTED THAT THE REMOTE MONITOR REMAINS FROZEN AND BEEPING ON TELEMETRY PHASE WHEN SENDING MANUAL TRANSMISSION. IT WAS MENTIONED THAT THE REMOTE MONITOR WAS NOT PICKING UP SIGNAL WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). IT WAS VERIFIED THAT THE REMOTE MONITOR REMAINED SET UP. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR SENT A SUCCESSFUL TRANSMISSION SINCE THE DATE OF THE CALL. THE PATIENT WAS REFERRED TO CLINIC. THE MONITOR 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 22438958 ↗
• MalfunctionMay 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MONITOR WAS NOT SENDING THE DAILY WIRELESS AUDITS, AND THE PATIENT WAS UNABLE TO SEE THE DATE ON THE MACHINE. ADDITIONALLY, THERE WAS NO PROGRESS BAR OR RESPONSE WHEN THE READER WAS PLACED OVER THE IMPLANTABLE CARDIAC MONITOR (ICM), INDICATING A TELEMETRY ISSUE. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE MONITOR, WHICH DID NOT RESOLVE THE ISSUE, AND ATTEMPTING TO VERIFY BATTERY STATUS THROUGH TRANSMISSION, WHICH WAS UNSUCCESSFUL. THE MONITOR WAS REASSIGNED, BUT THE PATIENT WAS NOT AVAILABLE TO CONTINUE TROUBLESHOOTING AND PLANNED TO CALL BACK LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059078 ↗
• MalfunctionMay 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO GET TELEMETRY OVER THE IMPLANTABLE CARDIAC MONITOR (ICM) DURING MANUAL TRANSMISSION ATTEMPTS. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE MONITOR, ATTEMPTING MANUAL TRANSMISSION, AND LEAVING THE MONITOR CHARGING FOR ONE HOUR, BUT TELEMETRY WAS STILL NOT ACHIEVED. THE PATIENT WAS REFERRED TO A CLINIC FOR A DEVICE CHECK PROCESS TO BE PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014730 ↗
• MalfunctionMar 19, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED AN ELECTRICAL RESET DURING INTERROGATION. 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 21640424 ↗
• MalfunctionMar 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED NO TELEMETRY WITH THE REMOTE MONITOR. IT WAS ALSO VERIFIED THAT THE IMPLANTABLE DEVICE WAS OVER FOUR YEARS OLD; AND SUSPECTED TO BE END OF SERVICE (EOS) BUT THE PATIENT REMOTE MONITORING NETWORK WAS NOT SHOWING BATTERY LEVEL. THE PATIENT WAS REFERRED TO THE CLINIC FOR A DEVICE CHECK. 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 21560489 ↗
• MalfunctionFeb 7, 2025Over-Sensing; Battery Problem; Over-Sensing; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED T-WAVE OVERSENSING (TWOS). IT WAS FURTHER NOTICED THE ICM HAD REACHED END OF SERVICE (EOS). IT WAS ALSO REPORTED THAT A CARELINK TRANSMISSION WAS NOT EXPORTED TO FOCUSON FOR REVIEW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332054 ↗
• MalfunctionFeb 5, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) PATIENT THAT THE DEVICE GOT 'DISLODGED'. IT WAS FURTHER REPORTED THAT BEDSIDE MONITOR MADE A BEEPING SOUND AND ALSO HAD THE WRONG DATE DISPLAYED. 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 21310631 ↗
• MalfunctionJan 16, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED UNDERSENSING. IT WAS FURTHER NOTED THAT THE CARELINK TRANSMISSION FAILED TO EXPORT 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 21166147 ↗
• MalfunctionJan 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE PATIENT CAN ONLY SEE ANIMATION OF PERSON HOLDING READER OVER CHEST. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE AND 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 21053868 ↗
• MalfunctionNov 26, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO A CLINIC FOR FURTHER EVALUATION. THE REMOTE 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 20787608 ↗
• MalfunctionNov 26, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED INTERMITTENT R WAVE 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 20786493 ↗
• MalfunctionNov 13, 2024Battery Problem; Communication or Transmission Problem; Battery 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 PATIENT WAS REFERRED TO THE CLINIC. THE REMOTE MONITOR REMAINS IN USE. 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 20672097 ↗
• MalfunctionOct 29, 2024Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE  IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED AN ELECTRICAL RESET. IT WAS FURTHER NOTED THAT THE REMOTE MONITORING REPORT WENT BACK TO THE DATE OF IMPLANT. 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 20556112 ↗
• MalfunctionSep 16, 2024Battery Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS INDICATED THAT THE ICM HAD REACHED END OF SERVICE (EOS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20222873 ↗
• MalfunctionAug 15, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED OCCASIONAL VENTRICULAR 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 19989893 ↗
• MalfunctionJul 22, 2024Over-Sensing; Unable to Obtain Readings; Under-Sensing; Over-Sensing; Unable to Obtain Readings; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED UNDERSENSING AND OVERSENSING. IT WAS FURTHER REPORTED THAT THE ICM EXHIBITED INVALID HISTOGRAM DATA. 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 19790575 ↗