LINQ II™ LNQ22 (UDI 00763000554002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,709 adverse event reports that list this exact device (DI 00763000554002), received between Jul 8, 2021 and Sep 30, 2026 — classified as 214 injuries, 5,495 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (1,042 reports).

2 FDA recall records 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

2. Jan 18, 2022Terminated

   Devices may lose functionality due to susceptibility to moisture ingress.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 5,709 reports, 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, 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 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) exhibited a full electrical reset. It was further noted that the reason for monitoring was invalid displaying ?? marks. 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 50896432 ↗
• MalfunctionSep 24, 2026Under-Sensing

  It was reported that the Implantable Cardiac Monitor (ICM) experienced false pause episodes due to under sensing. 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 50882727 ↗
• MalfunctionSep 22, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 21 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 50854355 ↗
• MalfunctionSep 22, 2026Signal Artifact/Noise

  It was reported that the Implantable Cardiac Monitor (ICM) detected false tachycardia episodes due to noise. 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 50853934 ↗
• MalfunctionSep 21, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837000 ↗
• MalfunctionSep 21, 2026Reset Problem

  It was further reported that the Implantable Cardiac Monitor's (ICM) device clock and parameters were reprogrammed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836752 ↗
• MalfunctionSep 18, 2026Reset Problem; Data Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset. It was noted that the device clock had been impacted. It was further noted that there was no record of the reset in the remote monitoring network and no file available. It was additionally noted that the patient activator was unable to beep to mark a symptom. It was further reported that remote monitoring network report had implant date was incorrect. 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 50817199 ↗
• InjurySep 17, 2026Migration or Expulsion of Device

  It was reported that the Implantable Cardiac Monitor (ICM) had migrated and caused patient discomfort. The ICM was explanted. The ICM was returned to the manufacturer, analysed, and tested out of specification. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800582 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50753806 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50753708 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50753545 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50753407 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50753249 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50752988 ↗
• MalfunctionSep 14, 2026Output Problem

  During an internal review of data, it was noted that the Implantable Cardiac Monitor¿s (ICM) electrocardiogram exhibited a change in signal quality, leading to consistent minor or major noise. This noise pattern indicated the device was not performing as intended. 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 50752822 ↗
• MalfunctionSep 14, 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 50750007 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardiac Monitor (ICM) exhibited premature battery depletion. 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 50730501 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardiac Monitor (ICM) was 'rejected' by the patient's body and came out of the patient. A new ICM was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Pocket Erosion

  MAUDE report 50713706 ↗