CapSure®SP Novus 4092-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00681490110716), received between Dec 9, 2016 and Sep 8, 2026 — classified as 3 deaths, 126 injuries, 56 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (53 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 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. Additionally, it was noted that the patient experienced palpitations. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Palpitations

  MAUDE report 50673461 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia. The Implantable Pulse Generator (IPG) system and previously capped Right Ventricular (RV) lead were explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50432878 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture, high undefined impedance, a polarity switch, noise and oversensing resulting in inhibition of pacing and misclassification of episode type. 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 50318258 ↗
• MalfunctionAug 12, 2026Unstable Impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223318 ↗
• InjuryJul 14, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED WITH 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 25811860 ↗
• MalfunctionMay 27, 2026Low impedance

  IT WAS REPORTED LESS THAN A WEEK POST ROUTINE GENERATOR CHANGE THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25298147 ↗
• MalfunctionMay 27, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN INAPPROPRIATE PACING. AND THE CLINICIAN REPORTS DEVICE IS NOT 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 25297758 ↗
• InjuryMay 18, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW 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 25201224 ↗
• InjuryApr 24, 2026Fracture

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE FRACTURED. BOTH LEADS WERE 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 24977198 ↗
• MalfunctionApr 23, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING AND EARLY TERMINATION OF EVENT RECORDINGS. 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 24964877 ↗
• MalfunctionMar 31, 2026Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF SYMPTOMS. IT WAS ALSO REPORTED THAT CROSS CHAMBER BLANKING LEADING TO FUNCTIONAL RIGHT VENTRICULAR (RV) LEAD UNDER SENSING AND FUNCTIONAL LOSS OF VENTRICULAR CAPTURE WAS OBSERVED. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24742018 ↗
• MalfunctionMar 23, 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 24662129 ↗
• InjuryFeb 19, 2026Signal 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 24388633 ↗
• InjuryJan 22, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24144050 ↗
• MalfunctionDec 10, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE SUBOPTIMAL 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 23767483 ↗
• MalfunctionNov 19, 2025Over-Sensing; Decreased Sensitivity; High Capture Threshold; Over-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, SHORT V-V INTERVALS AND LOW R WAVES. IT WAS FURTHER 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. THE RV LEAD AND 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 23592482 ↗
• InjuryOct 30, 2025Material Integrity Problem; Naturally Worn; Positioning Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Naturally Worn; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN IMPLANTATION PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INSULATION/APPEARANCE ISSUE. IT WAS NOTED THAT THE RV LEAD APPEARED "SHINY" AND QUESTIONABLE INTEGRITY OF THE LEAD STRUCTURE AT THE LOCATION IN WHICH THE PACING LEAD CONNECTS INTO DEVICE. IT WAS FURTHER NOTED THAT THE RV LEAD APPEARED LESS SUPPORTED AND A SUTURE SLEEVE WAS UTILIZED TO SECURE THE RV LEAD IN PLACE. 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 23422969 ↗
• MalfunctionOct 16, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. 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 23308621 ↗
• InjurySep 14, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND NO CAPTURE. 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 23047945 ↗
• 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 22990069 ↗
• InjuryAug 27, 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 22902933 ↗
• MalfunctionAug 8, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE INTERMITTENT UNDERSENSING ON RIGHT VENTRICULAR (RV) LEAD IN STORED 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 22747874 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREADTH AND SEVERE TRICUSPID REGURGITATION ATTRIBUTED TO RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22726227 ↗
• InjuryJul 28, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. THE RV LEAD WAS REPROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628634 ↗
• InjuryJun 18, 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 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 22282507 ↗