LINQ II™ LNQ22 (UDI 00763000613747)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,228 adverse event reports that list this exact device (DI 00763000613747), received between Jan 8, 2024 and Sep 30, 2026 — classified as 96 injuries, 1,132 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (579 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,228 reports, in the reporter's own words as published by the FDA.

• 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 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, 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 ↗
• MalfunctionSep 24, 2026Insufficient Device Problem Information

  The Implantable Cardiac Monitor (ICM) was returned to the manufacturer with no complaint information. During the manufacturer¿s preliminary analysis, the device did not meet longevity expectations. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883755 ↗
• MalfunctionSep 24, 2026Communication or Transmission Problem

  It was reported that the Implantable Cardiac Monitor (ICM) was unable to be interrogated with the diagnostic mobile programmer application. It was noted that a second tablet and patient connector were tried but the issue persisted. It was further noted that the ICM could not be palpated fully and there was a discussion about using X-ray to confirm the location of the implanted device. It was additionally reported that there were no transmissions received from the device to the remote monitoring network and it had issues connecting. 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 50882194 ↗
• MalfunctionSep 23, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced a full electrical reset while an episode was in progress due to Battery Supply Low. It was noted that the patient had a cardioversion procedure around the time that the reset had occurred. The ICM was re-programmed and reset in the remote monitoring network. 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 50865756 ↗
• MalfunctionSep 23, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced several electrical resets. It was confirmed that the patient had undergone a recent Pulmonary Vein Isolation (PVI) ablation. 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 50865336 ↗
• MalfunctionSep 22, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced multiple electrical resets. 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 50853175 ↗
• MalfunctionSep 22, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced multiple electrical resets. 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 50852489 ↗
• MalfunctionSep 21, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced multiple electrical resets, the most recent of which occurred due to Battery Supply Low. It was noted that the Reason for Monitoring (RFM) displayed question marks. 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 50837318 ↗
• MalfunctionSep 18, 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 50817932 ↗
• MalfunctionSep 17, 2026Unable to Obtain Readings

  It was reported that the mobile monitoring application's symptom marking was showing marked symptoms, but were not transmitted to Carelink and did not appear on the Implantable Cardiac Monitor (ICM). During troubleshooting it was confirmed that the patient was connected to the patient management database. Incident ticket was raised, patient was requested for the screenshot of application, and the call was transferred to another team for further investigation. 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 50799719 ↗
• MalfunctionSep 17, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced multiple electrical resets, including silent resets. The ICM was reprogrammed. 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 50799656 ↗
• MalfunctionSep 16, 2026Communication or Transmission Problem

  It was reported that the Implantable Cardiac Monitor (ICM) could not be interrogated. On review the ICM had not transmitted since (b)(6) 2026, it was noted that at that time that the ICM battery was 'good'. 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 50789130 ↗
• MalfunctionSep 15, 2026Communication or Transmission Problem; Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset either prior to or during implant and the ICM could not be interrogated as a result. The ICM was removed and replaced at a later date. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770214 ↗
• MalfunctionSep 14, 2026Inappropriate or Unexpected Reset

  It was reported that the Implantable Cardiac Monitor (ICM) experienced a partial electrical reset while an episode was in progress. It was noted that the remote monitoring network report Current Counters had question marks. The ICM was re-programmed and reset cleared. 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 50750370 ↗
• MalfunctionSep 14, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced an electrical reset due Battery Supply Low. It was noted that the patient had a cardioversion procedure on the same day as the reset. It was noted that the remote monitoring network report Current Counters had question marks. 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 50750104 ↗
• MalfunctionSep 14, 2026Reset Problem

  It was reported that the Implantable Cardiac Monitor (ICM) experienced multiple electrical resets. It was noted that the most recent reset occurred while an episode was in progress. 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 50749807 ↗
• MalfunctionSep 7, 2026Reset Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656849 ↗
• MalfunctionSep 7, 2026Reset Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656795 ↗