CAPSUREFIX NOVUSRecalls & reported problems across all models

We found 17 models of CAPSUREFIX NOVUS by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 27,547 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2013 and Sep 30, 2026 — classified as 310 deaths, 13,664 injuries, 13,572 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (8,219 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 CAPSUREFIX NOVUS problems

CAPSUREFIX NOVUS models

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

• Capsurefix® Novus 5076-52

  Permanent defibrillator electrodes
  111 deaths9,860 reports
• Capsurefix® Novus 5076-45

  permanent pacemaker Electrode
  85 deaths7,050 reports
• Capsurefix® Novus 5076-58

  Permanent defibrillator electrodes
  47 deaths4,587 reports
• CAPSUREFIX® NOVUS 407652

  permanent pacemaker Electrode
  40 deaths2,876 reports
• CAPSUREFIX® NOVUS 407645

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  12 deaths1,708 reports
• CAPSUREFIX® NOVUS 407658

  permanent pacemaker Electrode
  11 deaths813 reports
• CAPSUREFIX® NOVUS 407652

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death224 reports
• CAPSUREFIX® NOVUS 407645

  permanent pacemaker Electrode
  2 deaths180 reports
• CAPSUREFIX® NOVUS 5076-65

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  98 reports
• CAPSUREFIX® NOVUS 407658

  Permanent defibrillator electrodes
  86 reports
• CAPSUREFIX® NOVUS 5076-35

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  40 reports
• CAPSUREFIX® NOVUS 5076-85

  permanent pacemaker Electrode
  17 reports
• CAPSUREFIX® NOVUS 5076110

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 reports
• Capsurefix® Novus 407685

  Permanent defibrillator electrodes
  2 reports
• Capsurefix® Novus 407635

  permanent pacemaker Electrode
  1 report
• Capsurefix® Novus 407665

  permanent pacemaker Electrode
  1 death1 report
• CAPSUREFIX® NOVUS 4076110

  permanent pacemaker Electrode
  1 report

Recent CAPSUREFIX NOVUS adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50954560 ↗
• InjurySep 30, 2026Failure to Capture; Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951782 ↗
• InjurySep 30, 2026Signal Artifact/Noise; Impedance Problem

  It was reported that the Right Atrial (RA) lead exhibited noise and a change in impedance. The 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 50946794 ↗
• InjurySep 30, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead was capped and replaced. No patient complicat ions have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946359 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing on stored episodes. 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 50944008 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The lead remains in u se. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943950 ↗
• InjurySep 30, 2026Failure to Capture

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture. 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 50943371 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the patient attended the emergency room as they experienced dizziness and near-syncope. Upon device assessment it was noted that the Right Ventricular (RV) lead was over sensing non-physiologic intervals. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness; Presyncope

  MAUDE report 50943147 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The lead remains in u se. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943079 ↗
• MalfunctionSep 30, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited 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 50943032 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in appropriate atrial pacing and in termination of AT/AF detected event(s) in progress. 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 50942997 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing  triggering device classified false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) event(s) at times and a Atrial Lead Position Check failure. 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 50942892 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50934445 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency department due to pain at the pocket site. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Pain

  MAUDE report 50932758 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930259 ↗

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