Capsure® EPI 4968-35 (UDI 00613994492302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 940 adverse event reports that list this exact device (DI 00613994492302), received between Dec 9, 2016 and Sep 29, 2026 — classified as 14 deaths, 510 injuries, 416 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (240 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 940 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited loss of capture. it was further reported that the Right Ventricular (RV) lead exhibited under sensing resulting in failure to meet device classified episode detection criteria. The lead 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 50929645 ↗
• MalfunctionSep 29, 2026Failure to Capture

  It was reported that the Right Atrial (RA) lead exhibited loss of capture. it was further reported that the Right Ventricular (RV) lead exhibited under sensing resulting in failure to meet device classified episode detection criteria. The lead 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 50929644 ↗
• MalfunctionSep 28, 2026High Capture Threshold

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50923294 ↗
• InjurySep 25, 2026High impedance; High Capture Threshold

  It was reported that the Left Ventricular (LV) epicardial lead exhibited high capture thresholds and Out of Range (OOR) high undefined pacing impedance. It was further noted that there was a "LV ring issue." The lead was reprogrammed and 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 50902934 ↗
• InjurySep 23, 2026Signal Artifact/Noise; Break

  It was reported that during a revision the Right Atrial (RA) lead exhibited an insulation breach. During the revision the lead began to exhibited noise. A repair kit was successfully used to repair the insulation breach. Once it was repaired the lead noise ceased. The lead 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 50869277 ↗
• MalfunctionSep 23, 2026Capturing Problem; Unstable Impedance

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering Atrial Tachycardia/Atrial F ibrillation (AT/AF) episode misclassification, the RA lead also exhibited rising thresholds. The Right Ventricular (RV) lead exhibited varying impedances and rising thresholds. The leads remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866975 ↗
• MalfunctionSep 23, 2026Over-Sensing; Capturing Problem

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering Atrial Tachycardia/Atrial Fibrillation (AT/AF) episode misclassification, the RA lead also exhibited rising thresholds. The Right Ventricular (RV) lead exhibited varying impedances and rising thresholds. The leads remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866971 ↗
• MalfunctionSep 18, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817689 ↗
• InjurySep 14, 2026Break

  It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) lead both exhibited an insulation breach. Both leads were capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750561 ↗
• MalfunctionSep 14, 2026High impedance; High Capture Threshold

  It was reported that post-operative the epicardial Right Ventricular (RV) lead exhibited high threshold and high impedance. The epicardial RV lead 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 50750316 ↗
• MalfunctionSep 11, 2026Low impedance

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. It was also reported that the Right Atrial (RA) lead displayed low impedance and Right Ventricular (RV) lead exhibited rising thresholds. The IPG was explanted and replaced. Both the leads 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 50733950 ↗
• MalfunctionSep 11, 2026Capturing Problem

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. It was also reported that the Right Atrial (RA) lead displayed low impedance and Right Ventricular (RV) lead exhibited rising thresholds. The IPG was explanted and replaced. Both the leads 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 50733935 ↗
• InjurySep 11, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular pace (VP), which was addressed through reprogramming. It was further reported that the patient had an electrocardiogram indicating that the device was not tracking the patient¿s P-wave after some ventricular event. Further reprogramming was performed to address TWOS. The RV lead 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 50725733 ↗
• InjurySep 2, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568892 ↗
• InjurySep 2, 2026High impedance

  It was reported that the Right Ventricular (RV) lead triggered an alert for Out of Range (OOR) high impedance. It was further reported Right Atrial (RA) lead exhibited noise. The leads were capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568882 ↗
• InjurySep 2, 2026Break; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high impedance. It was further noted that the RV lead was damaged. The RV lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567289 ↗
• InjuryAug 31, 2026Failure to Capture; Capturing Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) epicardial lead began to exhibit rising/high thresholds. The device was reprogrammed at a higher output. The thresholds continued to rise and then the LV lead had no capture in any vector. The patient had worsening heart failure as a result. The lead was abandoned and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50518493 ↗
• InjuryAug 27, 2026Fracture; Over-Sensing

  It was reported that the patient experienced syncope. It was reported that the epicardial Left Ventricular (LV) lead exhibited a fracture and oversensing. The epicardial LV lead was capped and remains in the patient. It was reported that the Right Ventricular - Left Bundle Branch (RV-LBB) lead exhibited high thresholds, possible loss of capture, and high and variable impedance. The RV-LBB lead was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50469945 ↗
• MalfunctionAug 26, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454663 ↗
• InjuryAug 26, 2026Break

  It was reported that Insulation damage was noted on both the Right Atrial (RA) and Right Ventricular (RV) lead. During the revision procedure, the Implantable Pulse Generator (IPG) had intermittent connection issue along with pacing inhibition due to noise noted on the atrial channel when a new lead was connected. The IPG system was 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 50449875 ↗
• InjuryAug 26, 2026Break

  It was reported that Insulation damage was noted on both the Right Atrial (RA) and Right Ventricular (RV) lead. During the revision procedure, the Implantable Pulse Generator (IPG) had intermittent connection issue along with pacing inhibition due to noise noted on the atrial channel when a new lead was connected. The IPG system was 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 50449817 ↗
• InjuryAug 20, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave oversensing and the Cardiac Resynchronization Therapy Pacemaker (CRT-P) exhibited a detection issue. The RV lead and CRT-P remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50343422 ↗
• MalfunctionAug 19, 2026Pacing Problem; Under-Sensing

  Patient problems: Palpitations

  MAUDE report 50322378 ↗
• MalfunctionAug 18, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297018 ↗
• MalfunctionAug 7, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176277 ↗