LINQ IIRecalls & reported problems across all models

We found 3 models of LINQ II by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 7,610 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2020 and Sep 30, 2026 — classified as 341 injuries, 7,269 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (1,846 reports).

2 FDA recall records name at least one of these models by its device 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. 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

LINQ II 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 ↗

Most reported LINQ II problems

LINQ II models

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

• LINQ II™ LNQ22

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  2 recalls5,709 reports
• LINQ II™ LNQ22

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  1 recall1,228 reports
• LINQ II™ LNQ22

  DETECTOR AND ALARM, ARRHYTHMIA
  2 recalls673 reports

Recent LINQ II 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 ↗
• 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, 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 ↗
• MalfunctionSep 25, 2026Migration or Expulsion of Device

  Patient problems: Discomfort; Pain

  MAUDE report 50896860 ↗
• MalfunctionSep 25, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset while an episode was in progress due to a Battery Supply Low.  It was indicated that the patient may of had a recent cardioversion procedure. 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 50896760 ↗
• MalfunctionSep 25, 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 50896646 ↗
• MalfunctionSep 25, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset due to Power Supply Low. It was noted that the patient had an ablation procedure around the time that the reset had occurred. 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 50896503 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls