CAPSURE® SENSE 457445Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00885074200941), received between Aug 4, 2015 and Sep 28, 2026 — classified as 1 death, 86 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (154 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  It was reported that the patient experienced an arrhythmia. The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Arrhythmia

  MAUDE report 50912520 ↗
• MalfunctionJun 12, 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. LOW P WAVES NOTED. 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 25492789 ↗
• InjuryJun 10, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD UNDERSENSING RESULTING IN INAPPROPRIATE PACING DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NS-VT) EPISODES. THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25454762 ↗
• MalfunctionJun 5, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED A WARNING FOR HIGH/UNDEFINED IMPEDANCE. 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 25408545 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AFTER THE PATIENT WAS PROGRAMMED TO AN MAGNETIC RESONANCE IMAGING (MRI) SAFE MODE, THE PATIENT EXPERIENCED DISCOMFORT, AN ELEVATED HEART RATE, DID NOT FEEL WELL, AND FELT "FLUSHED". THE PATIENT WAS HOSPITALIZED AND REPROGRAMMED OUT OF THE MRI SAFE MODE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 25390868 ↗
• MalfunctionJun 2, 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 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 25362240 ↗
• MalfunctionMay 7, 2026Pacing 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, WITH INAPPROPRIATE ATRIAL PACING NOTED 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 25109934 ↗
• MalfunctionApr 30, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING FALSE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTIONS. 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 25043640 ↗
• MalfunctionApr 21, 2026Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN UNNECESSARY VENTRICULAR PACING AT TIMES. 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 24937497 ↗
• MalfunctionApr 14, 2026Over-Sensing

  IT WAS REPORTED THAT BY THE PATIENT THAT THEY FELT A VIBRATION FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT'S FOLLOWING CLINIC REVIEWED A REMOTE MONITORING TRANSMISSION AND THERE WERE NO RECENT AUDIBLE TONES EMITTED FROM THE ICD. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE ICD AND RA 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 24876290 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24797444 ↗
• MalfunctionMar 23, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE AS ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) DETECTION. 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 24662606 ↗
• MalfunctionJan 22, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE DETECTION. 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 24145651 ↗
• MalfunctionJan 15, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH IMPEDANCE. IT WAS FURTHER NOTED 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 RA AND 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 24078409 ↗
• MalfunctionJan 9, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING AND BLANKING RESULTING IN POSSIBLE MISCLASSIFICATION OF 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 24019157 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 24012259 ↗
• MalfunctionJan 6, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISDOES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS 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 23975328 ↗
• MalfunctionDec 22, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF), RESULTING IN INAPPROPRIATE ATRIAL PACING 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 23871982 ↗
• MalfunctionNov 27, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND UNNECESSARY PACING. 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 23665734 ↗
• MalfunctionNov 19, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING AT/AF STORED EPISODES RESULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (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 23594781 ↗
• InjuryOct 21, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS WERE MISCLASSIFIED AS VENTRICULAR FIBRILLATION (VF) DUE TO UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD WHICH RESULTED IN THERAPY BEING DELIVERED. IT WAS NOTED THAT THE RA LEAD HAD LOW P-WAVE AMPLITUDE. 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 23348117 ↗
• MalfunctionSep 9, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  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 23002386 ↗
• MalfunctionSep 8, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING. 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 22999047 ↗
• MalfunctionAug 27, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN IN FALSE AT/AF EPISODE DETECTION. 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 22904483 ↗
• MalfunctionAug 20, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT STORED ELECTROGRAMS REVEALED POSSIBLE UNDERSENSING ON THE ATRIAL LEAD, RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION DETECTION AND INAPPROPRIATE ATRIAL PACING. THE RIGHT ATRIAL (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 22849529 ↗