Capsure®SP Novus 559445Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00613994250230), received between Dec 9, 2015 and Sep 28, 2026 — classified as 1 death, 53 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (54 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 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 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 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 50911330 ↗
• MalfunctionSep 23, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under and over sensing resulting in inappropriate pacing. It was also reported that the RA lead exhibited intermittent undersensing noted on stored episodes which resulted in false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. Low P waves were also observed 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 50865937 ↗
• MalfunctionSep 11, 2026Under-Sensing; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high capture thresholds. It was also noted that atrial undersensing occurr ed during Atrial Tachycardia/Atrial Fibrillation (AT/AF). No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725476 ↗
• MalfunctionMay 25, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED UNDER SENSING. 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 25268318 ↗
• MalfunctionApr 16, 2026Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE IN REFRACTORY PERIOD AND 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 24902937 ↗
• MalfunctionMar 24, 2026Under-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 24681678 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PATIENT EXPERIENCED A BACTEREMIA INFECTION. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24507553 ↗
• MalfunctionFeb 9, 2026Pacing Problem; Under-Sensing

  IT WAS FURTHER REPORTED VIA FOLLOW-UP WITH THE CLINIC THAT THE CRTD THERAPIES WERE DEEMED APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290287 ↗
• InjurySep 19, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH RIGHT ATRIAL (RA) LEAD THRESHOLDS. THE IPG WAS EXPLANTED AND REPLACED. 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 23094108 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, EROSION, PAIN, AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Medical device site infection; Pain

  MAUDE report 23032377 ↗
• MalfunctionAug 18, 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 22833825 ↗
• MalfunctionJul 25, 2025Decreased Sensitivity; Capturing Problem; Decreased Sensitivity; Capturing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A SUDDEN DECREASE IN LONGEVITY DUE TO AN INCREASE IN RIGHT VENTRICULAR (RV) LEAD THRESHOLD. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASE IN THRESHOLD AND DECREASE IN P WAVE MEASUREMENT. IT WAS NOTED THAT THE IPG EXHIBITED A FALSE LOW IMPEDANCE WARNING ON THE RA LEAD. THE IPG AND 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 22608173 ↗
• MalfunctionJun 16, 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 (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 22209654 ↗
• MalfunctionMay 30, 2025Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE UNDERSENSING ON STORED ELECTROGRAMS (EGM). THE RA LEAD REMAINS IN USE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROGRAMMED VVIR. IT WAS NOTED THAT THE RA LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113731 ↗
• MalfunctionMar 18, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND STARTED ALERTING FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED PER TRANSMISSION REPORT THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH ATRIAL THRESHOLD. THE LEAD REMAINS IN USE AND THE DEVICE 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 21633602 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Under-Sensing; Electrical /Electronic Property Problem; Under-Sensing

  IT WAS FURTHER REPORTED THAT RA LEAD EXHIBITED POTENTIAL ATRIAL UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF AT/AF EVENT(S) AT TIMES.

  Patient problems: Chest Pain; Dizziness; Presyncope

  MAUDE report 21273477 ↗
• InjuryJan 17, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A CONFIRMED FRACTURE AND THE LEAD TIP BROKE OFF AND COMPLETELY SEPARATED FROM LEAD BODY. DUE TO POTENTIAL INADEQUATE LEAD SLACK, TENSION WAS PLACED ON THE LEAD WHEN THE PATIENT STOOD, PLACING TENSION ON LEAD BODY WHERE IT ATTACHED TO LEAD TIP AND OVER TIME CAUSED FRACTURE. THE RA 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 21177759 ↗
• MalfunctionNov 22, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED GROSS UNDERSENSING NOTED ON STORED 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 20757304 ↗
• MalfunctionNov 20, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WAS POSSIBLE RIGHT ATRIAL (RA) LEAD CAPTURE ISSUES NOTED ON A STORED ELECTROGRAM (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 20736406 ↗
• MalfunctionOct 30, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM) WITH CLASSIFIED TERMINATION OF ONGOING ATRIAL 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 20565679 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO AN INFECTION. A NEW SYSTEM WAS SUBSEQUENTLY IMPLANTED APPROXIMATELY ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20515694 ↗
• MalfunctionOct 17, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING ON CURRENT ELECTROGRAMS (EGM). 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 20471413 ↗
• MalfunctionOct 8, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS POSSIBLE RIGHT ATRIAL (RA) LEAD OVERSENSING OF FAR FIELD R-WAVE (FFRW) CAUSING FALSE DETECTION OF ATRIAL 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 20402826 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POSSIBLE INFECTION LESS THAN TWO WEEKS POST GENERATOR CHANGE. THERE WAS LOTS OF SWELLING AT THE DEVICE SITE AND IT WAS TENDER TO TOUCH. 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 20123282 ↗
• MalfunctionApr 11, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT DUE TO LOW OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS NOTED THAT THE MEASUREMENT AT THE TIME OF THE ALERT WAS 0 OHMS. 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 19093277 ↗