Capsure EPIRecalls & reported problems across all models

We found 10 models of Capsure EPI by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,344 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2015 and Sep 29, 2026 — classified as 53 deaths, 2,042 injuries, 1,249 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (858 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. 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

Most reported Capsure EPI problems

Capsure EPI models

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

• Capsure® EPI 4968-35

  permanent pacemaker Electrode
  14 deaths940 reports
• Capsure® EPI 4968-25

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  13 deaths843 reports
• Capsure® EPI 4968-60

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  12 deaths459 reports
• Capsure® EPI 4968-35

  Permanent defibrillator electrodes
  6 deaths438 reports
• Capsure® EPI 4965-35

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  207 reports
• Capsure® EPI 4965-25

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths133 reports
• Capsure® EPI 4965-15

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death129 reports
• Capsure® EPI 4965-35

  permanent pacemaker Electrode
  3 deaths92 reports
• Capsure® EPI 4965-15

  Permanent defibrillator electrodes
  68 reports
• Capsure® EPI 4965-50

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  35 reports

Recent Capsure EPI adverse event reports

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

• MalfunctionSep 29, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited undersensing. 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 50933336 ↗
• MalfunctionSep 29, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933308 ↗
• 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 25, 2026Break; Fracture; Mechanical Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported that during attempted removal of a lead pin from a pediatric Implantable Pulse Generator (IPG) header the lead remained trapped in the port. The setscrew and grommet were completely removed and lead was stuck. Lead was then held static and the generator was attempted to be "twisted" off the lead. The lead insulation breached and pulled away, exposing the conductors. The pin was removed from device port. The Lead was capped and replaced. The pediatric IPG was also removed and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895443 ↗
• 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 ↗
• MalfunctionSep 18, 2026Capturing Problem; Impedance Problem

  It was reported that the Right Atrial (RA) lead exhibited significant increase in bipolar impedance and capture thresholds along with decrease in P waves. The RA 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 50815844 ↗
• MalfunctionSep 17, 2026Failure to Capture

  It was reported that the Right Atrial (RA) leads exhibited loss of capture. Both RA 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 50803483 ↗
• MalfunctionSep 17, 2026Failure to Capture

  It was reported that the Right Atrial (RA) leads exhibited loss of capture. Both RA 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 50803481 ↗
• MalfunctionSep 17, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The RA 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 50801094 ↗

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