CAPSURE® SENSE 407452Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 00885074200644), received between Feb 8, 2014 and Sep 29, 2026 — classified as 4 deaths, 108 injuries, 69 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (66 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 181 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Capture

  It was reported that the patient experienced syncope. The Right Ventricular (RV) lead capture could not be confirmed as the Implantable Pulse Generator (IPG) had reached Recommended Replacement Time (RRT). The RV lead remains in use. The IPG was explanted and replaced as it had reached normal Elective Replacement Indicator (ERI). No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50933101 ↗
• InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Ventricular (RV) lead was capped and a new lead placed a couple of years ago with no information provided on the reason for replacement. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50154491 ↗
• 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 25390870 ↗
• MalfunctionMay 18, 2026Unstable Impedance

  IT WAS REPORTED THAT THERE WAS A VARIATION IN THE RIGHT VENTRICULAR (RV) LEADS IMPEDANCE. 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 25201330 ↗
• InjuryMay 6, 2026Failure to Capture; Fracture; High impedance; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE HIGH IMPEDANCE, NO CAPTURE, OVERSENSING, UNDERSENSING AND LEAD FRACTURE. THE LEAD WAS CAPPED AND A LEADLESS PACEMAKER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091869 ↗
• MalfunctionApr 29, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN PRETERMINATION OF VENTRICULAR ARRHYTHMIA AND UNNECESSARY VENTRICULAR PACING. 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 25026663 ↗
• MalfunctionMar 23, 2026Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND FAILED A POSITION CHECK. 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 24662384 ↗
• MalfunctionMar 23, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED EPISODES. 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 24661454 ↗
• MalfunctionFeb 20, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED BIPOLAR AND UNIPOLAR IMPEDANCE WARNINGS FOR CHRONIC HIGH IMPEDANCE. 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 24399970 ↗
• MalfunctionFeb 5, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF EPISODE AND UNNECESSARY PACING. 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 24266188 ↗
• MalfunctionJan 15, 2026High impedance; Impedance Problem

  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 24078407 ↗
• 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 24012231 ↗
• InjuryDec 17, 2025Low impedance; Material Split, Cut or Torn; Low impedance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INSULATION DAMAGE WHERE THE INSULATION WAS CUT AND EXHIBITED LOW IMPEDANCE. THE RV LEAD WAS CAPPED AN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827318 ↗
• InjuryDec 1, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. 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 23680460 ↗
• InjuryOct 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED 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 23335871 ↗
• InjurySep 15, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT FAR FIELD R-WAVE (FFRW) OVERSENSING OCCURRED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE TRENDS WERE SLOWLY CLIMBING IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. REPROGRAMMING SUCCESSFULLY ELIMINATED FAR FIELD R WAVE OVERSENSING. ALERT THRESHOLDS FOR THE RIGHT VENTRICULAR LEAD WERE ADJUSTED, AND FUNCTION WAS AS EXPECTED. THE CALLER WILL CONTINUE TO MONITOR THE RIGHT VENTRICULAR LEAD IMPEDANCES. 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 23048803 ↗
• MalfunctionSep 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 22993122 ↗
• InjuryAug 14, 2025Electrical /Electronic Property Problem; High impedance; Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE AND HAD A POLARITY SWITCH. 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 22802318 ↗
• MalfunctionAug 1, 2025High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED HIGH THRESHOLDS, AN RV BIPOLAR LEAD HIGH IMPEDANCE WARNING AS WELL AS A GRADUAL INCREASE NOTED IN BIPOLAR TRENDS OVER THE PAST YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684555 ↗
• InjuryJun 9, 2025Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON NON-MAGNET AND STORED ELECTROGRAMS (EGM). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 22165150 ↗
• InjuryJun 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 EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 22132640 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) THE DEVICE HAD ERODED THROUGH THE SKIN AND WAS VISIBLE. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 21925886 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTEREMIA INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 21651661 ↗
• MalfunctionFeb 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. 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 21352909 ↗
• MalfunctionJan 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD.  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 21161609 ↗