CapSure®SP Novus 5592-45 (UDI 00681490135696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 246 adverse event reports that list this exact device (DI 00681490135696), received between Feb 9, 2017 and Aug 18, 2026 — classified as 70 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (111 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 246 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296150 ↗
• MalfunctionAug 6, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155222 ↗
• MalfunctionJul 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED EPISODES RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NOISE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, WITH CURRENT THRESHOLDS REMAINING WITHIN NORMAL LIMITS AND ARE CONSISTENT. THE IPG WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). 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 25734295 ↗
• MalfunctionJul 1, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM) TRIGGERING FALSE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTIONS. 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 25676022 ↗
• MalfunctionJun 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT NO ACTION WAS TAKEN ON THE RA LEAD, DUE TO UNABLE TO DEMONSTRATE ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595255 ↗
• MalfunctionMay 14, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE/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 25170529 ↗
• MalfunctionApr 17, 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 24911602 ↗
• MalfunctionMar 20, 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 24649123 ↗
• MalfunctionMar 16, 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 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 24603038 ↗
• MalfunctionMar 10, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT NOISE/ ELECTROMAGNETIC INTERFERENCE (EMI) WAS OBSERVED ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE, WHICH TRIGGERED EPISODE MISCLASSIFICATION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RIGHT ATRIAL (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 24557202 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24549882 ↗
• MalfunctionFeb 18, 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 FALSE TERMINATION OF DEVICE CLASSIFIED AT/AF. THE LEAD REMAINS IN USE. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375843 ↗
• MalfunctionFeb 13, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. 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 24331947 ↗
• MalfunctionJan 16, 2026Pacing Problem

  IT WAS REPORTED THAT THERE WAS ATRIAL EVENTS FALLING IN BLANKING/REFRACTORY 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 24093471 ↗
• MalfunctionNov 24, 2025Under-Sensing; Under-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 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 23632658 ↗
• MalfunctionNov 14, 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 TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES AND APPEARS TO RESULT IN 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 23552522 ↗
• InjuryNov 14, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. THE RA 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 23551985 ↗
• MalfunctionSep 15, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND 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 23050507 ↗
• MalfunctionSep 11, 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 TACHYCARDIA (AT)/ ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES AND APPEARS TO RESULT IN 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 23023858 ↗
• MalfunctionAug 27, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDER SENSING, TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENT(S) 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 22902190 ↗
• InjuryAug 20, 2025Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS CAPPED AND REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847722 ↗
• MalfunctionAug 14, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOTED ON STORED ELECTROGRAMS (EGM). 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 22802008 ↗
• MalfunctionJul 9, 2025Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD ON STORED ELECTROGRAMS (EGM) AND ALSO EXHIBITED ATRIAL UNIPOLAR LEAD IMPEDANCE WARNING. 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 22456466 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD ERODED THROUGH THE SKIN. THE IPG SYSTEM WAS REMOVED AND A TEMPORARY LEAD WAS IMPLANTED WHICH WAS ATTACHED TO THE IPG EXTERNALLY UNTIL THE PATIENT HAD A NEW SYSTEM IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 22369042 ↗
• MalfunctionJun 9, 2025Under-Sensing; 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) EVENTS 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 22166357 ↗