Capsure® EPI 4965-35 (UDI 00613994501776)Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00613994501776), received between Feb 13, 2017 and Sep 3, 2026 — classified as 3 deaths, 53 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Low impedance” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Over-Sensing

  It was reported that the Right Atrial (RA) epicardial lead exhibited Far Field R-Wave (FFRW) oversensing. 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 50585184 ↗
• MalfunctionJun 3, 2026Low impedance

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25373053 ↗
• MalfunctionJun 3, 2026Low impedance

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25373027 ↗
• MalfunctionMay 29, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED BOTH LOW AND HIGH IMPEDANCE WARNINGS. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN IMPEDANCE WARNING. 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 25327957 ↗
• InjuryApr 20, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. BOTH LEADS WERE 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 24923855 ↗
• InjuryApr 20, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. BOTH LEADS WERE 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 24923814 ↗
• InjuryApr 15, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW IMPEDANCE WARNING. IT WAS ALSO NOTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE AND MYOPOTENTIALS. THE IPG REMAINS IN USE AND THE LEAD REMAINS INACTIVATED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882572 ↗
• MalfunctionMar 4, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24504507 ↗
• MalfunctionMay 21, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE IN UNIPOLAR CONFIGURATION. 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 22059153 ↗
• MalfunctionMay 21, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE IN UNIPOLAR CONFIGURATION. 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 22059150 ↗
• InjuryApr 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SPIKE IN IMPEDANCE AS WELL AS HIGH IMPEDANCE. BOTH THE 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 21771204 ↗
• MalfunctionNov 14, 2024Under-Sensing; Low impedance; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS REPORTED POST OPERATIVE ON THE DAY OF IMPLANT THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE RA LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RV LEAD ALSO EXHIBITED SHORT VENTRICLE TO VENTRICLE (V-V) INTERVALS. THE RA LEAD AND THE RV 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 20684641 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT EXPERIENCE AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20630918 ↗
• InjuryOct 30, 2024Intermittent Capture; High impedance; Intermittent Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND INTERMITTENT CAPTURE. THE RV LEAD WAS EXPLANTED AND REPLACED BY AN EPICARDIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565642 ↗
• MalfunctionApr 17, 2024Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED ELECTROGRAMS (EGM) AND CHRONIC LOW LEAD IMPEDANCE WERE ALSO NOTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19123481 ↗
• InjuryApr 2, 2024Adverse 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED, AND THE LEFT VENTRICULAR (LV) LEAD WAS INACTIVATED. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19019057 ↗
• MalfunctionApr 1, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR LOW IMPEDANCE. THE LV 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 19015436 ↗
• MalfunctionMar 21, 2024Over-Sensing; Under-Sensing; Low impedance; Over-Sensing; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW IMPEDANCE WARNING AND FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS ALSO NOTED THAT THE RA LEAD WAS UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WHICH WAS MISCLASSIFIED AS NON-SUSTAINED VENTRICULAR TACHYCARDIA DUE TO THE UNDER SENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 18948077 ↗
• MalfunctionMar 20, 2024Failure to Capture; Over-Sensing; Pacing Problem; Failure to Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE OVERSENSING AND LOSS OF CAPTURE ALONG WITH FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AND INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 18940480 ↗
• MalfunctionFeb 23, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THEIR HEART RACING AND PALPITATIONS. IT WAS ALSO REPORTED THAT SINCE TWO DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT, THE EPICARDIAL RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW IMPEDANCE WARNING. THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED A LOW IMPEDANCE WARNING AND WAS UNABLE TO CONFIRM CAPTURE. 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 18766412 ↗
• InjuryJan 11, 2024Failure to Capture; High impedance; Under-Sensing; Failure to Capture; High impedance; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, UNSTABLE THRESHOLDS, HIGH THRESHOLDS,  INTERMITTENT CAPTURE AND OVERSENSING.  IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE, NON CAPTURE AND UNDERSENSING. 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 18490703 ↗
• InjuryJan 11, 2024Intermittent Capture; High impedance; Over-Sensing; High Capture Threshold; Unstable Capture Threshold; Intermittent Capture; High impedance; Over-Sensing; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, UNSTABLE THRESHOLDS, HIGH THRESHOLDS,  INTERMITTENT CAPTURE AND OVERSENSING.  IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE, NON CAPTURE AND UNDERSENSING. 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 18490697 ↗
• InjuryOct 2, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD WAS REPROGRAMMED TO NO AVAIL AND 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 17849913 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, SWELLING AND REDNESS. THE IPG WAS EXPLANTED AND THE RIGHT ATRIAL (RA) LEAD AND ;RIGHT VENTRICULAR (RV) LEAD WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 17508056 ↗
• MalfunctionJul 19, 2023Low impedance; Device Sensing Problem; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED BLANKING EVERY OTHER ATRIAL FLUTTER WAVE, CAUSING RIGHT VENTRICULAR (RV) LEAD PACING AT HIGHER RATES DUE TO TRACKING. THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED A LOW LEAD IMPEDANCE WARNING. 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 17348435 ↗