Medtronic LINQ Heart MonitorRecalls & reported problems across all models

We found 11 models of Medtronic LINQ Heart Monitor by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 19,366 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2014 and Sep 30, 2026 — classified as 3 deaths, 987 injuries, 18,376 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (5,672 reports).

3 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Medtronic LINQ Heart Monitor recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · 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 · names 2 of these models · Recall details · FDA record ↗

3. Jun 1, 2021Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Medtronic LINQ Heart Monitor problems

Medtronic LINQ Heart Monitor models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Reveal LINQ™ LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 recall7,581 reports
• LINQ II™ LNQ22

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  2 recalls5,709 reports
• Reveal LINQ TM LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 death1,592 reports
• LINQ II™ LNQ22

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  1 recall1,228 reports
• Reveal LINQ™ LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 death930 reports
• LINQ II™ LNQ22

  DETECTOR AND ALARM, ARRHYTHMIA
  2 recalls673 reports
• Reveal LINQ™ LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  431 reports
• Reveal LINQ™, Reveal® LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 death393 reports
• Reveal LINQ™ LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  1 recall343 reports
• Reveal LINQ™, Reveal® LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  307 reports
• Reveal LINQ™ LNQ11

  DETECTOR AND ALARM, ARRHYTHMIA
  179 reports

Recent Medtronic LINQ Heart Monitor adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Inappropriate or Unexpected Reset

  It was reported that the Implantable Cardiac Monitor (ICM) experienced a partial electrical reset due to Battery Supply Low. 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 50944603 ↗
• MalfunctionSep 30, 2026Under-Sensing; Device Sensing Problem

  The Implantable Cardiac Monitor (ICM) experienced false pause episodes due to undersensing. It was noted that the signal quality was too poor to continue use. The ICM has been explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944585 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 27 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. 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 50944511 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 29 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. 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 50944462 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing. It was further reported that the Remote Monitoring Report displayed ?? marks under Current Counters. 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 50944375 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing Premature Ventricular Contractions (PVC)'s. It was further reported that the remote monitoring report displayed ?? marks under Current Counters and Reason For Monitoring. 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 50944264 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise

  It was reported that the Implantable Cardiac Monitor (ICM) detected fast tachycardia episodes (FVT) due to noise. 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 50944169 ↗
• 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 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50938704 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Decreased Sensitivity

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932598 ↗
• MalfunctionSep 28, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914723 ↗
• MalfunctionSep 28, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset due to Battery Supply Low. It was reported that the patient had a cardioversion around this time. 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 50913027 ↗
• MalfunctionSep 28, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced a electrical reset due to a power supply related issue. 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 50912942 ↗
• 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 25, 2026Migration or Expulsion of Device

  Patient problems: Discomfort; Pain

  MAUDE report 50896860 ↗

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