CapSureZ NovusRecalls & reported problems across all models

We found 4 models of CapSureZ Novus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,202 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2013 and Sep 24, 2026 — classified as 12 deaths, 623 injuries, 567 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (299 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 CapSureZ Novus problems

CapSureZ Novus models

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

• CapSure®Z Novus 5554-45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death320 reports
• Capsure®Z Novus 5054-52

  permanent pacemaker Electrode
  6 deaths309 reports
• CapSure®Z Novus 5554-53

  permanent pacemaker Electrode
  3 deaths300 reports
• Capsure®Z Novus 5054-58

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths273 reports

Recent CapSureZ Novus adverse event reports

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

• DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator." The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done." The patient expired approximately 8 weeks later.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50883752 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50811348 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50811208 ↗
• MalfunctionSep 14, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The RV lead remains in use. 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 and resulting in termination of AT/AF detected event(s) in progress. 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 50751018 ↗
• MalfunctionSep 9, 2026Low impedance

  It was reported that the Right Atrial (RA) lead triggered an alert for out of range low pacing 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 50686907 ↗
• InjurySep 8, 2026High impedance

  It was reported that the patient experienced lethargy. The Right Atrial (RA) lead exhibited high impedance. The Implantable Pulse Generator (IPG) had reached its End of Service (EOS). The RA lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Lethargy

  MAUDE report 50663384 ↗
• InjurySep 3, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Impedance Problem

  It was reported that the patient experienced syncope and Right Ventricular (RV) lead exhibited loss of capture, non-physiologic inte rvals, and noise. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50583205 ↗
• InjuryAug 27, 2026Defibrillation/Stimulation Problem; Under-Sensing

  It was reported that the patient experienced shortness of breath and the Right Ventricular (RV) lead exhibited undersensing resulting in delay of an episode and early termination. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dyspnea

  MAUDE report 50478809 ↗
• MalfunctionAug 26, 2026High Capture Threshold

  It was reported that the patient experienced chest pain. Upon device assessment it was noted that the Right Ventricular (RV) lead exhibited under sensing resulting in inappropriate pacing. It was also reported that the Right Atrial (RA) lead exhibited high thresholds. Both leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain

  MAUDE report 50449556 ↗
• 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 50432541 ↗
• MalfunctionAug 10, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191466 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a suspected pocket infection. The Implantable Pulse Generator (IPG) system was explante d. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50142970 ↗
• MalfunctionJul 10, 2026Break; Over-Sensing; Unstable Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779207 ↗
• InjuryJul 6, 2026High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DIAGNOSTIC RESET. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. THE IPG AND 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 25716329 ↗
• MalfunctionJul 6, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING/NOISE, RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 25714097 ↗

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