CAPSURE SP NOVUS® 4592-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00885074200996), received between Apr 6, 2017 and Aug 19, 2026 — classified as 36 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (44 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 100 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in potential inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50326620 ↗
• MalfunctionJun 25, 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 25627007 ↗
• MalfunctionJan 7, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON CURRENT AND STORED ELECTROGRAMS (EGM) RESULTING IN UNNECESSARY PACING AT TIMES AND THERE WAS A FAILED ATRIAL LEAD POSITION CHECK. 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 23987762 ↗
• MalfunctionSep 2, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EVENT(S) AT TIMES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. 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 22942480 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED BY AN LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22858547 ↗
• MalfunctionJul 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 22529710 ↗
• MalfunctionJul 2, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A POTENTIAL FOR UNDERSENSING TRIGGERING DEVICE-CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) 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 22387539 ↗
• 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 22282479 ↗
• InjuryMay 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS POST CORONARY ARTERY BYPASS GRAFT. 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 21987816 ↗
• MalfunctionMar 28, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE ATTEMPT TO REMOVE THE RIGHT ATRIAL (RA) LEAD, THE LEAD BECAME STUCK IN THE SUPERIOR VENA CAVA (SVC). THE LEAD WAS CAPPED AND ABANDONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722475 ↗
• MalfunctionMar 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. WITH THE RA LEAD POTENTIALLY CAUSING FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EVENTS. 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 21689604 ↗
• InjuryMar 25, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED BY THE PATIENT THAT THE IPG BATTERY "WAS GOING DEAD" AND THEY BELIEVE THEIR WAS AN ISSUE WITH THE IPG DUE TO THE DIZZINESS. THE PATIENT FURTHER STATED THEIR WAS "STOOL" IDENTIFIED LIKE SOMEONE USED THE BATHROOM AND WIPED AND DIDN'T WASH HANDS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea; Hypersensitivity/Allergic reaction; Shaking/Tremors; Unspecified Infection; Vomiting; Weight Changes

  MAUDE report 21688850 ↗
• MalfunctionMar 5, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM) AND CHRONICALLY HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED EXTRACARDIAC STIMULATION IN SOME VECTORS. THE RA LEAD AND LEFT VENTRICULAR (LV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529322 ↗
• InjuryFeb 26, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO ATRIAL CAPTURE, AND THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. 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 21473647 ↗
• MalfunctionFeb 25, 2025Over-Sensing; Under-Sensing; Decreased Sensitivity; Over-Sensing; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING WITH SMALL P-WAVES AND SEVERE UNDERSENSING ON CURRENT 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 21459332 ↗
• MalfunctionJan 14, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN ISOLATED INSTANCE OF OVERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED M, ,ELEVATED SENSING INTEGRITY COUNTER (SIC) . 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 21152054 ↗
• MalfunctionJan 2, 2025Intermittent Capture; Over-Sensing; Pacing Problem; Intermittent Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISPLAYED OVERSENSING POTENTIALLY IMPACTING DETECTION. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND SENSING INTEGRITY COUNTER (SIC). ACCORDING TO A HEALTHCARE PROFESSIONAL, THE PATIENT WAS UNDERGOING A SURGICAL PROCEDURE AT THE TIME OF THE EPISODES. 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 21058912 ↗
• MalfunctionDec 2, 2024Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED FROM INFORMATION OBTAINED FROM FOLLOW-UP WITH THE CLINIC THAT THE PATIENT WAS HOSPITALIZED FOLLOWING THE HIGH-VOLTAGE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819085 ↗
• MalfunctionNov 26, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED 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 20785228 ↗
• MalfunctionAug 7, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF POSSIBLE NON-PHYSIOLOGIC NOISE. 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 19931714 ↗
• MalfunctionJul 22, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENT TO THE EMERGENCY DEPARTMENT (ED) FOR SHOCK, DIZZINESS AND WEAKNESS. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR  ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF).THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL UNDERSENSING. THAT WAS S NOTED ON STORED ELECTROGRAMS (EGM), WHICH POSSIBLY RESULTED IN LACK OF AT/ AF DETECTION, FALSE TERMINATION OF AT/ AF AND MISCLASSIFICATION OF EPISODES.  THE DEVICE AND LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801115 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET. THE CRT-D SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 19734325 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS NOTED THAT THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19652981 ↗
• MalfunctionJun 12, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOTED ON STORED ELECTROGRAMS (EGM) RESULTING IN POSSIBLE FALSE DETECTION OF ARRHYTHMIA. 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 19517514 ↗
• InjuryMay 1, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD 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 19219934 ↗