CapSureSP NovusRecalls & reported problems across all models

We found 14 models of CapSureSP Novus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,107 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2015 and Sep 28, 2026 — classified as 18 deaths, 1,067 injuries, 1,022 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (488 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 CapSureSP Novus problems

CapSureSP Novus models

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

• Capsure®SP Novus 5092-58

  Permanent defibrillator electrodes
  3 deaths350 reports
• CapSure®SP Novus 4092-52

  permanent pacemaker Electrode
  1 death307 reports
• Capsure®SP Novus 5092-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths294 reports
• CapSure®SP Novus 5592-45

  permanent pacemaker Electrode
  246 reports
• CapSure®SP Novus 4592-45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths237 reports
• CapSure®SP Novus 4092-58

  Permanent defibrillator electrodes
  3 deaths185 reports
• CapSure®SP Novus 4592-53

  permanent pacemaker Electrode
  1 death165 reports
• CapSure®SP Novus 5592-53

  Permanent defibrillator electrodes
  3 deaths140 reports
• Capsure®SP Novus 559445

  permanent pacemaker Electrode
  1 death126 reports
• Capsure®SP Novus 559453

  Permanent defibrillator electrodes
  48 reports
• CAPSURE®SP NOVUS 5592-45

  permanent pacemaker Electrode
  3 reports
• CAPSURE®SP NOVUS 5592-53

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 reports
• CAPSURE®SP NOVUS 5092-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 reports
• CAPSURE®SP NOVUS 5092-58

  permanent pacemaker Electrode
  1 report

Recent CapSureSP Novus adverse event reports

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

• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. 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 50911330 ↗
• MalfunctionSep 23, 2026High impedance; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds and out of range high impedance. 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 50869117 ↗
• MalfunctionSep 23, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under and over sensing resulting in inappropriate pacing. It was also reported that the RA lead exhibited intermittent undersensing noted on stored episodes which resulted in false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. Low P waves were also observed Both 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 50865937 ↗
• MalfunctionSep 23, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under and over sensing resulting in inappropriate pacing. It was also reported that the RA lead exhibited intermittent undersensing noted on stored episodes which resulted in false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. Low P waves were also observed Both 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 50865909 ↗
• MalfunctionSep 18, 2026Signal Artifact/Noise

  It was reported that the Right Atrial (RA) lead exhibited noise. 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 50815245 ↗
• MalfunctionSep 16, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794928 ↗
• MalfunctionSep 11, 2026Low impedance

  It was reported that the Right Atrial (RA) lead exhibited low impedance. 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 50731455 ↗
• InjurySep 11, 2026Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture, a lead fracture, oversensing resulting in inhibition of pacing and misclassification of episode type, noise, a polarity switch and high impedance. The RV lead was capped and was replaced by a leadless Implantable Pulse Generator (IPG). No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729766 ↗
• MalfunctionSep 11, 2026Under-Sensing; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high capture thresholds. It was also noted that atrial undersensing occurr ed during Atrial Tachycardia/Atrial Fibrillation (AT/AF). No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725476 ↗
• MalfunctionSep 10, 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 50709137 ↗
• MalfunctionSep 8, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. Additionally, it was noted that the patient experienced palpitations. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Palpitations

  MAUDE report 50673461 ↗
• InjurySep 8, 2026Failure to Capture

  It was reported that the patient experienced syncope. Upon device assessment it was noted that the Right Ventricular (RV) lead exhibited loss of capture. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50663379 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563085 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) system was explanted due to an infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50451158 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia. The Implantable Pulse Generator (IPG) system and previously capped Right Ventricular (RV) lead were explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50432878 ↗

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