LINQ II™ LNQ22 (UDI 00763000060374)Recalls & reported problems

Summary

The FDA's MAUDE database contains 673 adverse event reports that list this exact device (DI 00763000060374), received between Aug 27, 2020 and Sep 7, 2026 — classified as 31 injuries, 642 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (225 reports).

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

1 other recall cover devices cleared under the same FDA submission (K200795); 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 16, 2026.

Recalls naming this device

1. Nov 3, 2023Open, Classified

   It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

   Z-0421-2024 · Root cause: Process change control · Recall details · FDA record ↗

2. Jan 18, 2022Terminated

   Devices may lose functionality due to susceptibility to moisture ingress.

   Z-0782-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 673 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656789 ↗
• MalfunctionJun 10, 2026Battery Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIAC MONITOR EXPERIENCED A RECENT HARD ELECTRICAL RESET WITH AN ELECTRICAL RESET COUNT OF 128, WITH THE MOST RECENT RESET REASON REPORTED AS BATTERY SUPPLY LOW AND THE DEVICE CONSIDERED LIKELY AT END OF SERVICE. IT WAS ALSO REPORTED THAT PROGRAMMED PARAMETERS WERE DISABLED DUE TO A CODE COPY FAILURE AND THE DEVICE CLOCK RESET WITH INCORRECT LOCAL DATE AND TIME. 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 25455864 ↗
• MalfunctionMay 21, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS UNABLE TO PICK UP OR RECORD THE ICM PATIENT EPISODES. IT WAS NOTED THAT THE FOLLOWING CLINIC CONFIRMED THAT EVERYTHING WAS FINE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE THE CHECKING OF THE MONITOR CONNECTION BUT IT WAS DISCONNECTED AND THERE WERE TRANSMISSIONS FROM THE PREVIOUS DAY. 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 25247740 ↗
• MalfunctionMay 7, 2026Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED MULTIPLE ELECTRICAL RESETS, THE MOST RECENT WAS A FULL RESET DUE TO BATTERY SUPPLY LOW. IT WAS NOTED THAT THE ICM PATIENT HAD A CARDIOVERSION PROCEDURE AROUND THE TIME THAT THE RESET HAD OCCURRED. IT WAS FURTHER NOTED THAT THE DEVICE CLOCK HAD BEEN RESET. THE ICM PATIENT WILL ATTEND THE OFFICE TO HAVE THE DEVICE CLOCK 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 25109546 ↗
• MalfunctionApr 10, 2026Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED MULTIPLE ELECTRICAL RESETS, WITH THE MOST RECENT BEING A HARD RESET. IT WAS NOTED THAT THE PROGRAMMED PARAMETERS WERE DISABLED DUE TO A CODE COPY FAILURE, AND THE DEVICE CLOCK WAS RESET. THE DEVICE SHOULD FUNCTION AS EXPECTED FOLLOWING REPROGRAMMING OF THE DEVICE CLOCK. 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 24844127 ↗
• MalfunctionFeb 24, 2026Under-Sensing

  THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED FALSE PAUSE EPISODES DUE TO UNDERSENSING. IT WAS FURTHER NOTED THAT THERE WAS ALSO LOSS OF CONTACT WITH THE DEVICE. 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 24429217 ↗
• MalfunctionFeb 10, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) SUSPENDED AN ELECTROCARDIOGRAM (ECG) DURING A PAUSE EPISODE. IT WAS FURTHER REPORTED THAT THE CARELINK REPORT WAS UNABLE TO GENERATE TRENDS. AN ATTEMPT TO GENERATE THE REPORT WAS UNSUCCESSFUL. 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 24302742 ↗
• MalfunctionJan 23, 2026Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED MULTIPLE RESETS WITH THE MOST RECENT BEING A HARD RESET DUE TO BATTERY SUPPLY LOW. THIS WAS CONSISTENT WITH THE PATIENT HAVING CARDIOVERSION. THE RESET WAS CLEARED HOWEVER THE REASON FOR MONITORING WAS SHOWING ???. 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 24160041 ↗
• MalfunctionJan 20, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A PARTIAL ELECTRICAL RESET. TROUBLESHOOTING STEPS WERE PROVIDED TO RESOLVE THE 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 24117595 ↗
• MalfunctionDec 19, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR EXPERIENCED AN ELECTRICAL RESET. DEVICE INTERROGATION CONFIRMED THAT THE RESET WAS CLEARED AND THE DEVICE WAS SUCCESSFULLY INTERROGATED. THE PATIENT HAD UNDERGONE A RECENT ABLATION TWO WEEKS PRIOR TO THE DEVICE CHECK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848673 ↗
• MalfunctionDec 15, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A PARTIAL ELECTRICAL RESET. TROUBLESHOOTING STEPS WERE PROVIDED TO RESOLVE THE ISSUE. THE ICM SHOULD FUNCTION AS EXPECTED IN THE FUTURE. 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 23801343 ↗
• MalfunctionDec 11, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A SOFT ELECTRICAL RESET OCCURRED WITH AN IMPLANTABLE CARDIAC MONITOR THE SAME DAYS AS PATIENT HAD CARDIOVERSION. 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 23776941 ↗
• MalfunctionDec 11, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED MULTIPLE ELECTRICAL RESETS WITH THE MOST RECENT BEING A FULL ELECTRICAL RESET. IT WAS NOTED THAT THE PROGRAMMED PARAMETERS WERE DISABLED DUE TO THE CODE COPY FAILURE AND THE DEVICE CLOCK WAS ALSO RESET. TROUBLESHOOTING STEPS WERE PROVIDED TO RESOLVE THE ISSUE. THE DEVICE SHOULD FUNCTION AS EXPECTED FOLLOWING REPROGRAMMING OF THE DEVICE PARAMETERS AND DEVICE CLOCK. 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 23775875 ↗
• MalfunctionDec 2, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A PARTIAL ELECTRICAL RESET. TROUBLESHOOTING STEPS WERE PROVIDED TO RESOLVE THE 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 23691626 ↗
• MalfunctionNov 27, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIAC MONITOR UNDERWENT A HARD ELECTRICAL RESET, WHICH RESULTED IN CORRUPTED DEVICE COUNTERS AND A RESET OF THE DEVICE CLOCK. THE PATIENT HAD A CARDIOVERSION AROUND THIS TIME. THE PATIENT WAS IN THE CLINIC, AND THE HEALTHCARE PROVIDER INSTALLED THE RAMWARE AND CORRECTED THE DEVICE DATE AND TIME. THE DEVICE WAS EXPECTED TO FUNCTION AS INTENDED FOLLOWING REPROGRAMMING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666869 ↗
• MalfunctionNov 20, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A FULL ELECTRICAL RESET. IT WAS NOTED THAT THE DEVICE CLOCK WAS ALSO RESET. THE DEVICE SHOULD FUNCTION AS EXPECTED FOLLOWING REPROGRAMMING OF THE DEVICE CLOCK. 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 23607677 ↗
• MalfunctionOct 15, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED NOISE ON TACHYCARDIA EPISODES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292460 ↗
• MalfunctionAug 11, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED A PARTIAL ELECTRICAL RESET. 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 22768816 ↗
• MalfunctionAug 8, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  DURING AN INTERNAL REVIEW OF DATA, IT WAS IDENTIFIED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEPLETED PREMATURELY. 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 22747919 ↗
• MalfunctionAug 8, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  DURING AN INTERNAL REVIEW OF DATA, IT WAS IDENTIFIED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DEPLETED PREMATURELY. 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 22747870 ↗
• MalfunctionAug 7, 2025Appropriate 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 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 22735519 ↗
• MalfunctionJul 11, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) HAD EXPERIENCED MULTIPLE ELECTRICAL RESETS, THE MOST RECENT BEING A FULL ELECTRICAL RESET. THE PROGRAMMED PARAMETERS WERE DISABLED DUE TO A CODE COPY FAILURE AND THE DEVICE CLOCK WAS RESET. IT WAS NOTED THAT ADVISE WAS GIVEN TO BRING THE PATIENT IN-OFFICE AND TO INSTALL THE SOFT ELECTRICAL RESET INITIALIZATION FIX, THE DEVICE SHOULD FUNCTION AS EXPECTED FOLLOWING THE REPROGRAMMING OF THE DEVICE PARAMETERS AND 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 22477199 ↗
• MalfunctionJul 9, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS ASSOCIATED WITH FALSE-POSITIVE PAUSE EPISODES DUE TO UNDERSENSING, NO N-SUSTAINED VENTRICULAR TACHYCARDIA DURING UNDERSENSING. THE ISSUE WAS ADDRESSED BY ADVISING TO PROGRAM THE SENSITIVITY TO 0.025MV. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458207 ↗
• MalfunctionJul 7, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A PARTIAL ELECTRICAL RESET. IT WAS NOTED THAT THE PATIENT HAD A CARDIOVERSION PROCEDURE AROUND THE TIME THAT THE RESET OCCURRED. IT WAS FURTHER NOTED THAT THE ICM DID NOT HAVE THE SOFT ELECTRICAL RESET INITIALIZATION FIX INSTALLED AND THE BRADYCARDIA/ ASYSTOLE REJECTIONS WERE NOT SET UP CORRECTLY. TECHNICAL SERVICES CONFIRMED THAT THE RESET COULD BE CLEARED IN CARELINK BUT RECOMMENDED IN PERSON INTERROGATION TO UPGRADE THE SOFTWARE. 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 22411856 ↗
• MalfunctionJun 30, 2025Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED A FULL ELECTRICAL RESET. THE DEVICE CLOCK WAS ALSO RESET. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A CARDIOVERSION THAT MONTH. 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 22355744 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200795. One submission often covers many models, so check the product and lot details in each record.

• Z-2076-2021 · May 14, 2021 · Open, Classified
  Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only