Capsure® EPI 4965-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00613994501745), received between Apr 6, 2017 and Sep 10, 2026 — classified as 4 deaths, 90 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fracture” (40 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 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. 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 50713405 ↗
• MalfunctionJun 10, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE (OOR) LOW IMPEDANCE. 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 25457801 ↗
• InjuryMay 22, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FRACTURED. THE RV LEAD WAS PARTIALLY EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251900 ↗
• InjuryApr 2, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE HIGH IMPEDANCE AND EVIDENCE OF A FRACTURE. 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 24766146 ↗
• InjuryMar 2, 2026Human-Device Interface Problem

  IT WAS FURTHER REPORTED THAT THE LEAD WAS NOT IMPLANTED AFTER IT'S USE-BY-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489999 ↗
• InjuryFeb 27, 2026High impedance; Under-Sensing

  IT WAS REPORTED THAT POST-OPERATIVE THE PATIENT EXPERIENCED A FAST ATRIAL HEART RATE AND A WENCKEBACH PATTERN WAS NOTED ON THE PRESENTING ELECTROGRAMS (EGM). IT WAS REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD EXHIBITED IMPEDANCE THAT WAS HIGH AND UNDEFINED, AND ALSO EXHIBITED UNDERSENSING. SETTINGS WERE ADJUSTED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; Tachycardia

  MAUDE report 24467891 ↗
• MalfunctionJan 12, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE (OOR) LOW IMPEDANCE WARNING. 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 24037065 ↗
• MalfunctionDec 19, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CROSS TALK. 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 23848073 ↗
• InjuryDec 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. BOTH LEADS WERE 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 23740260 ↗
• MalfunctionNov 15, 2025Electrical /Electronic Property Problem; Under-Sensing; Electrical /Electronic Property Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCONSISTENT CAPTURE, HIGH IMPEDANCE, A POLARITY SWITCH AND A LEAD IM PEDANCE WARNING. THE RIGHT ATRIAL (RA) EXHIBITED OCCASIONAL OVERSENSING AND HAD AN ATRIAL LEAD POSITION CHECK (ALPC) FAILURE. 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 23563800 ↗
• InjuryOct 30, 2025Failure to Capture; High impedance; Under-Sensing; Failure to Capture; High impedance; Under-Sensing

  LITERATURE WAS REVIEWED REGARDING A PATIENT WHO HAD DEVELOPED PROTEIN-LOSING ENTEROPATHY (PLE) OWING TO LOW CARDIAC OUTPUT FROM BRADYCARDIA AND LACK OF ATRIOVENTRICULAR SYNCHRONY AFTER VENTRICULAR PACING LEAD FAILURE. THE AUTHORS DESCRIBED A PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT AFTER THEY HAD AN EVENT OF NEAR SYNCOPE AND A FALL WHILE WALKING, WITH ASSOCIATED VISUAL AURA, FATIGUE, LIGHTHEADEDNESS, AND EMESIS. PACEMAKER INTERROGATION SHOWED HIGH PACING IMPEDANCE ON THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD WITH NO SENSING OR CAPTURE. THE EPICARDIAL RIGHT ATRIAL (RA) LEAD HAD ALSO FAILED WITH A FRACTURE CONFIRMED VIA CHEST X-RAY. THE LEADS WERE CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

  Patient problems: Bradycardia; Dizziness; Fall; Fatigue; Presyncope; Visual Disturbances; Vomiting

  MAUDE report 23424743 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS BROKEN. THE RV 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 23093555 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS BROKEN. 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 23093407 ↗
• InjurySep 10, 2025Failure to Capture; High impedance; Low impedance; Failure to Capture; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE AND LOW IMPEDANCE WARNING IN UNIPOLAR CONFIGURATION AND UNDEFINED AND HIGH IMPEDANCE IN BIPOLAR CONFIGURATION. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE, ATRIAL UNIPOLAR LEAD WAS ALSO PROGRAMMED BIPOLAR, LEADING TO LEAD ISSUES AND HOSPITALIZATION FOR LOSS OF CAPTURE. THE PATIENT EXPERIENCED SYNCOPE. THE LEADS WERE CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23015998 ↗
• InjuryAug 26, 2025Intermittent Capture; High impedance; Intermittent Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT NON-CAPTURE AND OUT OF RANGE (OOR) HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE RV LEAD AND IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893331 ↗
• MalfunctionJun 18, 2025Low impedance; Impedance Problem; High Capture Threshold; Low impedance; Impedance Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THERE WAS DISSATISFACTION AS THE IPG EXHIBITED VARIATION IN THE EXPECTED BATTERY LONGEVITY SINCE IMPLANT, LASTING ONLY FOUR YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283601 ↗
• InjuryJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE FRACTURED. BOTH THE LEADS WERE PARTIALLY 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 22148794 ↗
• InjuryJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE FRACTURED. BOTH THE LEADS WERE PARTIALLY 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 22148782 ↗
• MalfunctionMay 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AND FALSE IMPEDANCE ALERT AND THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH. THE IPG AND 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 22050976 ↗
• MalfunctionMay 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AND FALSE IMPEDANCE ALERT AND THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH. THE IPG AND 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 22050964 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEADS WERE EXPLA NTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993538 ↗
• InjuryMay 9, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEADS WERE 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 21993517 ↗
• MalfunctionMar 13, 2025Electrical /Electronic Property Problem; High impedance; Low impedance; High Capture Threshold; Electrical /Electronic Property Problem; High impedance; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH ATRIAL IMPEDANCE AND THRESHOLDS. IT WAS NOTED THAT LOW ATRIAL IMPEDANCE AND A LEAD WARNING FOR RIGHT VENTRICULAR (RV) UNIPOLAR IMPEDANCE WAS OBSERVED. ADDITIONALLY, AN ATRIAL LEAD POSITION CHECK FAILURE WAS 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 21595343 ↗
• MalfunctionMar 13, 2025Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD IMPEDANCE HAS BEEN HISTORICALLY LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595264 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; High impedance; Low impedance; Electrical /Electronic Property Problem; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED BOTH INTERMITTENT AND COMPLETE LOSS OF CAPTURE AND WAS NOTED TO NOT BE PACING. THERE IS MULTIPLE SHORT CIRCUIT PACE (SCP) OR OPEN CIRCUIT PACE (OCP) COUNTS ON RIGHT ATRIAL (RA) LEAD AND RV LEAD. THE RA LEAD ALSO HAD A ATRIAL LEAD POSITION CHECK FAIL. THERE WAS ALSO A FALSE TRIGGER ALERT FOR ATRIAL LEAD IMPEDANCE OUT OF RANGE ON THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. THE PATIENT EXPERIENCED SYMPTOMS OF BRADYCARDIA, WITH HEART RATE AT FORTY BEATS PER MINUTE. THE RV LEAD WAS REPROGRAMMED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21523709 ↗