CAPSUREFIX® NOVUS 5076-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00681490730068), received between Apr 6, 2017 and Aug 18, 2026 — classified as 71 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (27 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 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Failure to Capture; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295796 ↗
• MalfunctionMay 11, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER PACING. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. 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 25139915 ↗
• MalfunctionApr 29, 2026Over-Sensing

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED A PARTIAL ELECTRICAL RESET WHERE DIAGNOSTIC DATA SUCH AS PACING PERCENTAGES AND RATE HISTOGRAMS WERE CLEARED, HOWEVER PARAMETER VALUES REMAINED UNCHANGED. A HIGH SENSING INTEGRITY COUNTER (SIC) WAS ALSO NOTED. THE DEVICE AND RIGHT VENTRICULAR (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 25026739 ↗
• InjuryApr 1, 2026Extracardiac stimulation; Capturing Problem; High Capture Threshold

  IT WAS REPORTED BY THE CLINICIAN THAT THE PATIENT'S LEFT PECTORAL IS "PULSING INVOLUNTARILY" AND THAT THEIR LEFT ARM IS "TWITCHING." IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN THRESHOLDS AND HIGH THRESHOLDS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Twitching

  MAUDE report 24753461 ↗
• InjuryFeb 9, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE AND HIGH IMPEDANCE. THE 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 24290810 ↗
• InjuryJan 28, 2026Electrical /Electronic Property Problem; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED  POST GENERATOR REPLACEMENT AND ALSO EXHIBITED HIGH UNDEFINED IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH IMPEDANCE, POLARITY SWITCH AND HIGH NUMBER OF SHORT V-V INTERVAL. BOTH THE LEADS 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 24201560 ↗
• MalfunctionNov 20, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN TERMINATION OF  ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENT(S) IN PROGRESS AND ALSO 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 23604485 ↗
• MalfunctionSep 9, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON STORED ELECTROGRAMS (EGM), RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION AND INAPPROPRIATE ATRIAL PACING. IT WAS ALSO NOTED THAT CAPTURE WAS UNABLE TO BE CONFIRMED FOR 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 23002402 ↗
• InjuryAug 26, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEAD WAS CAPPED AND REPLACED DUE TO INCREASED THRESHOLD OUTSIDE NORMAL RANGES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893428 ↗
• InjuryMay 30, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF). IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 22113119 ↗
• MalfunctionMay 20, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH HEART RATES IN THE TWENTIES TO THIRTIES, POSSIBLY DUE TO IMPLANTABLE PULSE GENERATOR (IPG) PACING BELOW THE PROGRAMMED RATE. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED LOSS OF CAPTURE NOTED ON STORED OR CURRENT ELECTROGRAMS (EGM). BOTH THE IPG AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22051164 ↗
• MalfunctionMar 7, 2025Under-Sensing; Decreased Sensitivity; High Capture Threshold; Under-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM), LOW R WAVES 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 21544866 ↗
• InjuryFeb 19, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408731 ↗
• MalfunctionJan 2, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. 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 21054554 ↗
• InjuryDec 11, 2024Adverse 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 AND REPLACED WITH A LEADLESS PACEMAKER DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20901414 ↗
• MalfunctionNov 8, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING, POSSIBLY PREMATURELY TERMINATING DETECTION OF A NON-SUS TAINTED VENTRICULAR TACHYCARDIA 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 20641256 ↗
• InjurySep 24, 2024Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED AT A ROUTINE DEVICE CHANGE OUT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294776 ↗
• InjuryAug 27, 2024Adverse 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 PATIENT DEVELOPED VEGETATION ON THE TRICUSPID VALVE AND BACTEREMIA. IT WAS NOTED THAT THE ORGANISM OF THE INFECTION WAS STREP GALLOLYTICUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NOFURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 20075061 ↗
• InjuryMay 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TORRENTIAL TRICUSPID REGURGITATION DUE TO RIGHT VENTRICULAR (RV) LEAD IMPINGEMENT. THE LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19357440 ↗
• InjuryMar 29, 2024Pacing Problem; Under-Sensing; Decreased Sensitivity; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING OF INTRINSIC R WAVES ON ELECTROCARDIOGRAM ( ECG) AND ELECTROGRAMS (EGM) AND OVER PACING NEAR THE T WAVE AND LOWER RATE INTERVAL TIMEOUT. INAPPROPRIATE PACING NOTED DUE TO THE UNDERSENSING AND CHRONICALLY LOW R WAVES WERE NOTED. THE LEAD WAS REPROGRAMMED AND 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 19002619 ↗
• InjuryMar 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED APPROXIMATELY FIVE DAYS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) THAT IT EXHIBITED A PROBLEM. THE IPG WAS EXPLANTED AND THE RA AND RV LEADS WERE INACTIVATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992930 ↗
• InjuryMar 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CONFIRMED FRACTURE. 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 18863950 ↗
• InjuryFeb 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD FRACTURE. THE RV LEAD WAS REPOSITIONED. IT WAS FURTHER REPORTED THAT 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 18777247 ↗
• InjuryJun 6, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT AFTER OPEN HEART SURGERY WITH A NEW TRICUSPID VALVE PLACED, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CONFIRMED FRACTURE. ADDITIONALLY THE LEAD EXHIBITED NOISE WITH ARM MOVEMENTS AND THERE WAS INHIBITION OF VENTRICULAR PRESSURE. SHORT V-AV INTERVALS WERE ALSO NOTED. 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 17069779 ↗
• InjuryMay 29, 2023Intermittent Capture; High impedance; Over-Sensing; High Capture Threshold; Intermittent Capture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON STORED ELECTROGRAMS (EGM), HIGH THRESHOLDS, LOSS OF CAPTURE INTERMITTENTLY, AN INCREASE IN IMPEDANCE THAT WAS NOW HIGH AND UNDEFINED AND HIGH SENSING INTEGRITY COUNTER (SIC) COUNTS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. THE RV AND RA 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 17017189 ↗