CapSure®SP Novus 4592-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00681490114974), received between Apr 6, 2017 and Jul 29, 2026 — classified as 1 death, 64 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (63 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 165 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026High Capture Threshold

  It was reported that the patient experienced syncope. It was further reported that the Right Atrial (RA) lead exhibited high thresholds. The lead was reprogrammed and remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50075296 ↗
• MalfunctionJun 29, 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 RIGHT ATRIAL (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 25653619 ↗
• MalfunctionMay 22, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPES. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED NOISE AND AN ATRIAL LEAD POSITION CHECK FAIL. 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 25252814 ↗
• 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 24909927 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND EROSION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection

  MAUDE report 24896258 ↗
• MalfunctionJan 21, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, INAPPROPRIATE PACING AND AN ATRIAL LEAD POSITION CHECK(ALPC) FAILURE. 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 24141181 ↗
• MalfunctionAug 22, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT IRREGULAR OVERSENSING AND NOISE WAS DETECTED ON THE ATRIAL LEAD DURING MONITORED ATRIAL TACHYCARDIA/ATRIAL FIBR ILLATION EPISODES. POCKET MANIPULATIONS COULD NOT REPRODUCE THE SENSING ISSUE, HOWEVER, INTERFERENCE WAS OBSERVED WITH THE PATIENT PRESSING THEIR HANDS TOGETHER. THE PATIENT IS BEING MONITORED WITH REGULAR FOLLOW-UP. THE RIGHT ATRIAL (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 22872450 ↗
• InjuryAug 20, 2025Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE RA LEAD CONTINUED TO EXHIBIT OVERSENSING AND NOISE AND HAD ANOTHER FAILED ATRIAL LEAD POSITION CHECK.

  Patient problems: Syncope/Fainting

  MAUDE report 22851838 ↗
• InjuryJun 24, 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. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22319186 ↗
• InjuryJun 13, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD FRACTURED RESULTED IN OVERSENSING OF NOISE DURING STORED EPISODES. HIGH AND RISING IMPEDANCE WAS NOTED AS WELL. THE RA LEAD WAS REPROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201610 ↗
• InjuryMay 21, 2025High impedance; Over-Sensing; High impedance; Over-Sensing

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059423 ↗
• MalfunctionMay 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED OR CURRENT ELECTROGRAMS (EGM). DOES NOT APPEAR TO BE TRUE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF)EVENT. 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 22000678 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED WITHOUT REPLACEMENT DUE TO INFECTION. THE ORGANISM WAS IDENTIFIED AS BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 21907059 ↗
• InjuryMar 28, 2025Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE AND NOISE. IT WAS NOTED THE LEAD HAD A POSSIBLE FRACTURE ALSO. IT WAS FURTHER NOTED THE LEAD WAS REPROGRAMMED. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717948 ↗
• MalfunctionMar 12, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN ABRUPT CHANGE IN ATRIAL LEAD IMPEDANCE MEASUREMENTS NOTED. 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 21582854 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED EROSION AND WOUND DEHISCENCE AND THE DEVICE MAIN UNIT WAS EXPOSED IN THE POCKET. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY ELEVATED THRESHOLDS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. SURGICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 21344363 ↗
• InjuryFeb 4, 2025Signal Artifact/Noise; Electrical /Electronic Property Problem; Signal Artifact/Noise; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AND THE RA LEAD EXHIBITED AN 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 21303039 ↗
• InjuryJan 13, 2025Break; Break

  IT WAS REPORTED THAT THE INSULATION OF THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WAS DAMAGED DURING IMPLANTABLE PULSE GENERATOR (IPG) CHANGE. THE RA LEAD AND RV LEAD WERE KINKED AND CUT. THE RA LEAD AND RV LEAD WERE 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 21134970 ↗
• InjuryJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A CONFIRMED FRACTURE. THE RA 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 21103157 ↗
• MalfunctionDec 5, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING 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 20851272 ↗
• MalfunctionDec 2, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT OVERSENSING 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 20821311 ↗
• MalfunctionNov 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A POLARITY SWITCH. 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 20756401 ↗
• InjuryNov 11, 2024Mechanical Problem; Over-Sensing; Mechanical Problem; Over-Sensing

  IT WAS REPORTED THAT POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE LEAD WAS REPROGRAMMED. APPROXIMATELY TWO WEEKS LATER, A SHOULDER ROTATION AND A STRESS TEST ON THE POCKET SITE WERE PERFORMED IN ORDER TO CHECK THE LEAD CONDITION AGAIN AT THE OUTPATIENT VISIT AND FURTHER OVERSENSING OCCURRED. ALSO, NO LOOSE PIN WAS OBSERVED IN THE PHOTOS WHEN CHECKING THE A CHEST X-RAY HOWEVER, A LOOSE PIN COULD NOT BE RULED OUT. THE SURGEON DECIDED NOT TO CHANGE THE SETTINGS AND CONTINUED TO FOLLOW-UP WITH THE LEAD REMAINING IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650618 ↗
• MalfunctionNov 1, 2024Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE ON ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WITH MIRROR DEFLECTIONS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, THE ATRIAL LEAD POSITION CHECK FAILED. THE RA LEAD AND THE RV 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 20587071 ↗
• MalfunctionJul 16, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS INTERMITTENT ATRIAL OVERSENSING OBSERVED ON STORED ELECTROGRAMS. THE RIGHT ATRIAL (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 19751132 ↗