CapSure®SP Novus 5592-53 (UDI 00681490135733)Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00681490135733), received between Jun 8, 2017 and Sep 10, 2026 — classified as 3 deaths, 54 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (61 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited 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 50709137 ↗
• InjuryJul 29, 2026Failure to Capture; Under-Sensing; Decreased Sensitivity

  It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia (AT)/Atrial Fibrillation (AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. A low P wave amplitude was noted. The RA also exhibited no capture. It was reported that the Right Ventricular (RV) lead exhibited under sensing. A low R wave amplitude was noted. The RA lead was programmed off. 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 50074897 ↗
• MalfunctionMay 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDER SENSING DURING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) STORED EPISODES, RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 25054985 ↗
• InjuryApr 24, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE RA LEAD WAS CAPPED AND REPLACED DUE TO A VISIBLE INSULATION BREACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986187 ↗
• MalfunctionApr 17, 2026Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI)/NOISE, OVERSENSING AND HIGH THRESHOLDS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EMI/NOISE ALSO. 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 24918378 ↗
• MalfunctionMar 25, 2026Electrical /Electronic Property Problem; Under-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. POLARITY SWITCH WAS ALSO OBSERVED. 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 24685742 ↗
• MalfunctionMar 4, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN INAPPROPRIATE PACING AND 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 24510865 ↗
• MalfunctionJan 8, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A POLARITY SWITCH. 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 24001820 ↗
• MalfunctionDec 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. 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 23779319 ↗
• InjuryOct 21, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR RISING IMPEDANCE AND EXHIBITED OVERSENSING ON STORED EGMS RESULTING IN INAPPROPRIATE PACING. THE RA LEAD REMAINS IN USE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23347981 ↗
• InjuryOct 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACEMENT WITH A LEADLESS PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278446 ↗
• InjuryAug 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED HEART RATES. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 22782374 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION, AND FOR THE DEVICE ERODING THROUGH THE PATIENT'S SKIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22753143 ↗
• MalfunctionJul 31, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WHICH COULD BE MISCLASSIFYING AT/AF EVENTS. 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 22673401 ↗
• InjuryJul 14, 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 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 22502602 ↗
• MalfunctionJul 1, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POTENTIAL UNDERSENSING ON 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 22369686 ↗
• InjuryJun 10, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE AND OVERSENSING OF ATRIAL PACING. IT WAS ALSO NOTED THE RV LEAD WAS OVERSENSING AND EXHIBITED RISING THRESHOLDS. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN ATRIAL LEAD POSITION CHECK FAILURE. THE RA AND RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED RISING IMPEDANCE. THE RA AND RV LEADS EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS NOTED TO BE FRACTURED. THE LEADS WERE EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE RA LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175953 ↗
• MalfunctionMay 30, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED ELECTROGRAMS (EGM). THE OVERSENSING WAS SUSPECTED TO BE ELECTROMAGNETIC INTERFERENCE (EMI) DETECTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ON THE ATRIAL CHANNEL, HOWEVER AN EMI SOURCE HAD NOT YET BEEN CONFIRMED. THE ICD 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 22114792 ↗
• MalfunctionMay 28, 2025Electrical /Electronic Property Problem; Over-Sensing; Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. UPON DEVICE ASSESSMENT IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS BOTH EXHIBITED OVER SENSING. THE RV LEAD EXHIBITED OVER SENSING OF SHORT V-V INTERVALS. AN ATRIAL LEAD POSITION CHECK FAILURE WAS ALSO REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 22093976 ↗
• InjuryMay 2, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE PACING LEADS EXHIBITED LOW IMPEDANCES AND THE "PATIENT HAD TOLD THEM THAT ONE OF THE LEADS WAS NOT FUNCTIONING PROPERLY AND WAS NOT CONNECTED". WITH THE EXCEPTION OF THE LOW IMPEDANCES THE LEAD TESTING WAS NORMAL. THE LEADS WERE REPROGRAMMED AND 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 21948933 ↗
• MalfunctionMar 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IT WAS NOTED THAT THE DEVICE IS NOT CLASSIFYING EPISODE AS VENTRICULAR TACHYCARDIA (VT), IT IS SIMPLY DETECTED IN THE VT MONITOR ZONE WITHOUT DISCRIMINATORS APPLIED. THE CRT-D REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED SIGNIFICANT ATRIAL UNDERSENSING NOTED DURING EPISODE. 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 21693872 ↗
• MalfunctionMar 13, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS FURTHER REPORTED THAT RA LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS WAS RESULTING IN TERM INATION OF AT/AF DETECTED EVENT(S) IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592900 ↗
• MalfunctionMar 3, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 21505063 ↗
• InjuryMar 3, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21502184 ↗
• MalfunctionFeb 25, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD OVERSENSING AND UNDERSENSING ON STORED FAST VENTRICULAR TACHYCARDIA (FVT). 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 21459526 ↗