CAPSURE SP NOVUSRecalls & reported problems across all models

We found 4 models of CAPSURE SP NOVUS by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 250 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 25, 2026 — classified as 1 death, 89 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (109 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 SP NOVUS problems

CAPSURE SP NOVUS models

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

• CAPSURE SP NOVUS® 4592-45

  permanent pacemaker Electrode
  1 death146 reports
• CAPSURE SP NOVUS® 4592-53

  permanent pacemaker Electrode
  100 reports
• CAPSURE SP NOVUS® 4092-52

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

  Permanent defibrillator electrodes
  2 reports

Recent CAPSURE SP NOVUS adverse event reports

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

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50895760 ↗
• InjurySep 8, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing during in office threshold testing. It was noted that the patient recently underwent an Atrioventricular node ablation procedure. The RA 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 50674796 ↗
• InjuryAug 19, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in potential inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50326620 ↗
• MalfunctionAug 17, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50282112 ↗
• InjuryAug 10, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. 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 50193190 ↗
• MalfunctionJun 25, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING 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 25627007 ↗
• MalfunctionJun 11, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Under-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEART RATE BELOW THE PROGRAMMED LOWER RATE OF THE IMPLANTABLE PULSE GENERATOR (IPG). 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. IT WAS REPORTED THAT THE RA LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED A DECREASE IN BIPOLAR AND UNIPOLAR IMPEDANCES. IT WAS NOTED THAT THE PATIENT UNDERWENT A BYPASS PROCEDURE ON THE SAME DAY. THE IPG AND THE RA LEAD 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 25467943 ↗
• MalfunctionMay 27, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AND INAPPROPRIATE ATRIAL 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 25301899 ↗
• MalfunctionMay 21, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER-PACING. 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 25238913 ↗
• MalfunctionApr 7, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. 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 24800398 ↗
• InjuryApr 2, 2026Signal Artifact/Noise; Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INSULATION DAMAGE AND INTERMITTENT NOISE. THE LEAD 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 24762477 ↗
• MalfunctionMar 30, 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 24728048 ↗
• MalfunctionMar 30, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING DURING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EPISODES. 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 24725925 ↗
• MalfunctionMar 26, 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 AND RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. LOW P WAVES WERE NOTED AS WELL. 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 24704263 ↗
• MalfunctionMar 11, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. 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 24574044 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls