CapSure®SP Novus 4092-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 00681490110655), received between Feb 9, 2017 and Sep 16, 2026 — classified as 1 death, 174 injuries, 132 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (92 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 307 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794928 ↗
• InjurySep 11, 2026Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture, a lead fracture, oversensing resulting in inhibition of pacing and misclassification of episode type, noise, a polarity switch and high impedance. The RV lead was capped and was replaced by a leadless Implantable Pulse Generator (IPG). No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729766 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) system was explanted due to an infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50451158 ↗
• MalfunctionAug 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296160 ↗
• InjuryAug 4, 2026Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead had a suspected fracture and exhibited high impedance. The RV 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 50128652 ↗
• MalfunctionJun 11, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE 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 25467864 ↗
• MalfunctionMay 15, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) 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 25181085 ↗
• MalfunctionMay 13, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). THE 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 25158453 ↗
• MalfunctionMay 7, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING, RESULTING IN INAPPROPRIATE PACING. THE 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 25111450 ↗
• MalfunctionApr 30, 2026Over-Sensing

  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 25042071 ↗
• MalfunctionApr 24, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN THRESHOLDS AND HIGH THRESHOLDS. THE 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 24977104 ↗
• MalfunctionApr 17, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DIAGNOSTIC RESET. ADDITIONALLY, IT WAS REPORTED THAT THE RA LEAD EXHIBITED LOW IMPEDANCE. BOTH LEADS AND IPG 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 24908056 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 24797434 ↗
• MalfunctionMar 30, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER SENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. IT WAS ALSO REPORTED THAT THE RV LEAD DISPLAYED HIGH NUMBER OF SHORT V-V INTERVALS AND CHRONIC HIGH THRESHOLDS. THE 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 24727803 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND EROSION AT THE LEFT PACEMAKER IMPLANT SITE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection

  MAUDE report 24543307 ↗
• MalfunctionFeb 12, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS. THE 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 24321355 ↗
• 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 24247459 ↗
• InjuryJan 7, 2026Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE. THE RV LEAD WAS PARTIALLY 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 23988004 ↗
• InjuryDec 30, 2025Failure to Capture; Fracture; High impedance; High Capture Threshold; Failure to Capture; Fracture; High impedance; High Capture Threshold

  IT WAS FURTHER REPORTED THAT WHEN THE PHYSICIAN REMOVED THE IPG FROM THE DEVICE POCKET, IMPEDANCE ROSE HIGH OUT OF RANGE AND THE RV LEAD WAS UNABLE TO MAINTAIN CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922472 ↗
• MalfunctionDec 4, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING AND HIGH THRESHOLDS, RISING AND HIGH IMPEDANCE AND NOISE. A FRACTURE WAS SUSPECTED. THE RA LEAD WAS CAPPED AND REPLACED AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND OVERSENSING. THE 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 23719966 ↗
• MalfunctionSep 5, 2025High Capture Threshold; 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 22976772 ↗
• InjurySep 3, 2025Pacing Problem; Adverse Event Without Identified Device or Use Problem; Pacing 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 EXPLANTED DUE TO TO POCKET INFECTION AND LOW PACING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22951112 ↗
• MalfunctionJul 18, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE UNDER SENSING ON THE RIGHT VENTRICULAR (RV) LEAD ON SOME ELECTROGRAMS (EGM) RESULTING IN VENTRICULAR 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 22541415 ↗
• MalfunctionJul 7, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LETHARGY. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 22409883 ↗
• InjuryJun 25, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. 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 22329915 ↗