CAPSURE SP NOVUS® 4592-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00885074200989), received between Dec 9, 2016 and Sep 8, 2026 — classified as 1 death, 50 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (64 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50282112 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION OF UNKNOWN ORIGIN. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED A FEVER. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A R ESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 24247457 ↗
• MalfunctionDec 22, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE DETECTION. 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 23861987 ↗
• MalfunctionNov 4, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN UNNECESSARY PACING AT TIMES. 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 23465155 ↗
• MalfunctionSep 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041238 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY HAD AN INFECTION AND IT WAS POSSIBLE THAT THE SOURCE OF THE INFECTION COULD BE THE IMPLANTED DEVICE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22990063 ↗
• MalfunctionAug 21, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R WAVE OVERSENSING DURING RECORDED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AND APPEAR TO BE FALSE. 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 22862491 ↗
• MalfunctionAug 1, 2025Failure to Capture; Pacing Problem; Under-Sensing; Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOXIA. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING AND FALSER TERMINATION OF ONGOING ATRIAL ARRHYTHMIA. IT WAS ALSO NOTED THAT THE RA LEAD EXHIBITED NO CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: Hypoxia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685405 ↗
• MalfunctionJul 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEADS EXHIBITED POTENTIAL PERFORMANCE ISSUE. BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (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 22574927 ↗
• InjuryJul 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FLUTTER AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. THE RA LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter

  MAUDE report 22477737 ↗
• MalfunctionMay 12, 2025Pacing Problem; Under-Sensing; Pacing 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) AT TIMES AND APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING AT TIMES. 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 22000523 ↗
• MalfunctionMay 2, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED A PARTIAL ELECTRICAL RESET WHERE DIAGNOSTIC DATA SUCH AS PACING PERCENTAGES AND RATE HISTOGRAMS WERE CLEARED, HOWEVER PARAMETER VALUES REMAINED UNCHANGED. THE DEVICE REMAINS IN USE. DURING EVALUATION OF THE DEVICE, FAR FIELD R-WAVE (FFRW) OVERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD ON CURRENT ELECTROGRAMS (EGM), NO EPISODES DETECTED, BUT NOTED CARDIAC COMPASS HAS LOW AMOUNT OF ATRIAL FIBRILLATION (AF) 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 21948354 ↗
• MalfunctionMar 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM). 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 21686530 ↗
• MalfunctionFeb 21, 2025Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing; Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARS TO BE UNDER SENSING, AFFECTING MODE SWITCH AND RESULTING IN INAPPROPRIATE ATRIAL PACING. IT WAS ALSO NOTED THAT THERE WAS AN ATRIAL LEAD POSITION CHECK FAILURE. THE PATIENT "SPACED OUT" WHILE EATING DINNER. LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21430436 ↗
• InjuryJan 21, 2025Pacing Problem; Under-Sensing; Decreased Sensitivity; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON CURRENT AND STORED ELECTROGRAMS (EGM) WHICH RESULTED IN FALSELY CLASSIFIED TERMINATION OF ONGOING ATRIAL ARRHYTHMIA. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197563 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION RESULTING IN EROSION AND THE DEVICE PROTRUDING OUTSIDE THE BODY. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20911365 ↗