CapSure®SP Novus 4592-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 00681490114943), received between Feb 9, 2017 and Sep 11, 2026 — classified as 2 deaths, 100 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (80 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 237 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Low impedance

  It was reported that the Right Atrial (RA) lead exhibited low impedance. 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 50731455 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563085 ↗
• MalfunctionMay 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED EPISODES RESULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION. 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 25060067 ↗
• MalfunctionApr 30, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, OVERSENSING, ELEVATED THRESHOLDS AND THE ATRIAL LEAD POSITION CHECK FAILED. THE LEADS 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 25042093 ↗
• MalfunctionApr 21, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES, RESULTING IN UNNECESSARY PACING AT TIMES AND PRE-TERMINATION OF EVENTS 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 24941020 ↗
• InjuryMar 3, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24494687 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE "MAIN UNIT" IS EXPOSED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24162196 ↗
• MalfunctionJan 9, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS 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 24028821 ↗
• MalfunctionJan 5, 2026Intermittent Capture; Over-Sensing; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED VARIABLE THRESHOLDS. IT ALSO REPORTED THAT THE RA LEAD DISPLAYED OVER SENSING AND INTERMITTENT CAPTURE 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 23969274 ↗
• MalfunctionOct 15, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE INTERMITTENT OVERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. IT WAS ALSO REPORTED THAT THE 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 23299230 ↗
• MalfunctionSep 15, 2025Intermittent Capture; Electrical /Electronic Property Problem; Intermittent Capture; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE ALONG WITH 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 23049462 ↗
• MalfunctionSep 5, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONIC OVERSENSING DETECTED AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND CHRONIC HIGH THRESHOLDS. THESE SHOWED AS NON-PHYSIOLOGIC RATES AND MORPHOLOGIES. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED CHRONIC HIGH THRESHOLDS. THE RA AND RV LEADS 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 22976784 ↗
• MalfunctionSep 4, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS FURTHER REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WHICH APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING ON SAVED ELECTROGRAMS (EGM). IT WAS FURTHER REPORTED THAT THE DEVICE ALSO APPEARS TO BE UNDER SENSING ON THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS 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 22963343 ↗
• InjuryJul 18, 2025Signal Artifact/Noise; Pacing Problem; Signal Artifact/Noise; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED PACING INHIBITION AND WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540267 ↗
• InjuryJul 9, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING FURTHER CAUSING DEVICE CLASSIFIED FALSE DETECTION OF ATRIAL TACHYCARDIA (AT)/ ATRIAL FIBRILLATION (AF). ADDITIONALLY, ATRIAL UNDERSENSING WAS NOTED ON EPISODES. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 22456685 ↗
• MalfunctionJul 8, 2025Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AND LOW P WAVES. 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 22436187 ↗
• MalfunctionJul 8, 2025Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FRACTURE, NO CAPTURE AND HIGH 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 22434954 ↗
• InjuryJun 30, 2025Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLD INCREASED SIGNIFICANTLY AND SUBSEQUENTLY EXHIBITED HIGH THRESHOLDS. 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 22356001 ↗
• MalfunctionMay 29, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL 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 22103441 ↗
• MalfunctionMay 28, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD TRIGGERED ALERTS FOR OUT OF RANGE (OOR) LOW IMPEDANCE. THE LEADS 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 22094202 ↗
• InjuryMay 23, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE RA LEAD WAS CAPPED AND REPLACED. THE R IGHT VENTRICULAR (RV) LEAD WAS CAPPED 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 22078022 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED 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 22000859 ↗
• MalfunctionMar 26, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) 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 21698372 ↗
• MalfunctionMar 10, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISPLAYED POTENTIAL 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 21559867 ↗
• MalfunctionJan 27, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT HAD A FALL. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. INTERMITTENTLY FAR-FIELD OVERSENSING WITH POSSIBLE R AND T WAVES OBSERVED ON THE RA LEAD DURING THE AT/AF. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 21238921 ↗