Capsure® EPI 4968-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 459 adverse event reports that list this exact device (DI 00613994492340), received between Dec 9, 2016 and Sep 17, 2026 — classified as 12 deaths, 234 injuries, 213 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (121 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 459 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Capture

  It was reported that the Right Atrial (RA) leads exhibited loss of capture. Both RA 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 50803483 ↗
• MalfunctionSep 17, 2026Failure to Capture

  It was reported that the Right Atrial (RA) leads exhibited loss of capture. Both RA 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 50803481 ↗
• MalfunctionSep 14, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high impedance during a shoulder procedure. 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 50751276 ↗
• MalfunctionSep 7, 2026Over-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646950 ↗
• MalfunctionSep 3, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under sensing during ventricular arrhythmia. 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 50586123 ↗
• MalfunctionAug 28, 2026Failure to Capture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499899 ↗
• InjuryAug 27, 2026High Capture Threshold

  Patient problems: Bradycardia

  MAUDE report 50474576 ↗
• InjuryAug 27, 2026High Capture Threshold

  It was reported that both the Right Ventricular (RV) epicardial leads exhibited high thresholds and the patient was bradycardic. Both leads were inactivated and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50473850 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and fever. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) and the Right Atrial (RA) lead were explanted.  The epicardial Left Ventricular (LV) lead the epicardial Right Ventricular (RV) lead were partially explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50436183 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and fever. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) and the Right Atrial (RA) lead were explanted. The epicardial Left Ventricular (LV) lead the epicardial Right Ventricular (RV) lead were partially explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50436099 ↗
• MalfunctionAug 14, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249953 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced ongoing concerns related to Cardiac Resynchronization Therapy Defibrillator (CRT-D) follow-up and cardiac evaluation. The patient reported shortness of breath, dizziness, left-sided pain, leg edema, and difficulty walking, and stated that they had been told they had an obstruction and needed additional workup, including blood testing and an echocardiogram with contrast. The patient also reported that their CareLink monitor was not online and that there were delays and difficulties with follow-up care and referral coordination. The patient expressed frustration that the recommended evaluation and testing had not yet been completed. The CRT-D system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Dyspnea; Obstruction/Occlusion; Pain; Peripheral Edema

  MAUDE report 50195224 ↗
• InjuryJul 30, 2026Failure to Capture; High impedance; Decreased Sensitivity; Capturing Problem; High Capture Threshold

  It was reported that the patient experienced dizziness and bradycardia. It was also reported that the Right Ventricular (RV) lead exhibited loss of capture, rising thresholds, high thresholds, diminished sensing and triggered an alert for Out of Range (OOR) high impedance. The lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 50079752 ↗
• InjuryJul 29, 2026Fracture

  It was reported that during implant the Right Ventricular (RV) lead pin was fractured. The lead was attempted not used and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066943 ↗
• MalfunctionJul 9, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING AND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND HAD AN IMPEDANCE WARNING. THE RA AND RV 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 25765693 ↗
• MalfunctionJun 29, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND AN ATRIAL LEAD POSITION CHECK FAILURE. IT WAS ALSO REP ORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CROSS CHAMBER OVERSENSING AND A HIGH NUMBER OF SHORT VENTRICLE TO VENTRICLE (V-V) INTERVALS. THE RA LEAD AND THE RV 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 25649252 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND AN ATRIAL LEAD POSITION CHECK FAILURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CROSS CHAMBER OVERSENSING AND A HIGH NUMBER OF SHORT VENTRICLE TO VENTRICLE (V-V) INTERVALS. THE RA LEAD AND THE RV 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 25649246 ↗
• InjuryJun 16, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, INHIBITION OF PACING AND ONE BEAT OF FAILURE TO CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS KNOWN NOT TO HAVE CAPTURE AND WAS PROGRAMMED OFF. IT WAS ALSO NOTED THAT THE RV LEAD IMPEDANCE TRENDS SHOW SLIGHT VARIABILITY IN BIPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517728 ↗
• MalfunctionJun 11, 2026Failure to Capture

  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 AND TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS. THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED NO CAPTURE. THE LEFT VENTRICULAR (LV) LEAD EXHIBTED NO CAPTURE. 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 25470705 ↗
• MalfunctionJun 3, 2026Low impedance; High Capture Threshold

  IT WAS REPORTED APPROXIMATELY THREE MONTHS POST IMPLANT THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND FAR FIELD R-WAVE (FFRW) OVERSENSING WHILE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCE. 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 25372962 ↗
• MalfunctionJun 3, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED APPROXIMATELY THREE MONTHS POST IMPLANT THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND FAR FIELD R-WAVE (FFRW) OVERSENSING WHILE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCE. 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 25372961 ↗
• InjuryMay 25, 2026Failure to Capture

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE PATIENT EXPERIENCED BLEEDING. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) CAPTURE MANAGEMENT WAS ABORTED DUE TO HIGH CAPTURE THRESHOLDS. LOSS OF CAPTURE WAS OBSERVED ON THE RV AND LEFT VENTRICULAR (LV) LEAD. UNDERSENSING WAS NOTED ON THE RV LEAD WHICH RESULTED IN INAPPROPRIATE PACING. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25268925 ↗
• InjuryMay 25, 2026Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE PATIENT EXPERIENCED BLEEDING. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) CAPTURE MANAGEMENT WAS ABORTED DUE TO HIGH CAPTURE THRESHOLDS. LOSS OF CAPTURE WAS OBSERVED ON THE RV AND LEFT VENTRICULAR (LV) LEAD. UNDERSENSING WAS NOTED ON THE RV LEAD WHICH RESULTED IN INAPPROPRIATE PACING. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND BOTH LEADS 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 25268906 ↗
• InjuryMay 21, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). REPROGRAMMING WAS PERFORMED AND 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 25246626 ↗
• MalfunctionMay 18, 2026High Capture Threshold

  IT WAS REPORTED THAT THERE HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. 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 25201995 ↗