Capsure® EPI 4965-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00613994501813), received between Dec 9, 2016 and Sep 17, 2026 — classified as 17 injuries, 18 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (8 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Over-Sensing

  It was reported that the Right Atrial (RA) 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 50801094 ↗
• MalfunctionJul 8, 2026Signal Artifact/Noise; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED AND VARYING PACING IMPEDANCES. IN ADDITION, NON-PHYSIOLOGIC SIGNALS WERE NOTED ON THE LVTIP TO RVCOIL PACING VECTOR ELECTROGRAMS (EGM). 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 25750748 ↗
• MalfunctionMay 29, 2026High impedance; Low impedance

  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 25328004 ↗
• InjuryOct 23, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A FRACTURE. THE LV LEAD WAS 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 23366580 ↗
• MalfunctionMay 20, 2025Break; Over-Sensing; Pacing Problem; Impedance Problem; Break; Over-Sensing; Pacing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED AND INSULATION BREACH WITH OVERSENSING, PACING INHIBITION AND POSSIBLE IMPEDANCE ISSUE. 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 22052255 ↗
• MalfunctionMay 20, 2025Break; Over-Sensing; Pacing Problem; Impedance Problem; Break; Over-Sensing; Pacing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED AND INSULATION BREACH WITH OVERSENSING, PACING INHIBITION AND POSSIBLE IMPEDANCE ISSUE. 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 22052253 ↗
• InjuryJun 28, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD WAS REPROGRAMMED 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 19631312 ↗
• MalfunctionApr 15, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE LOSS OF CAPTURE. ADDITIONAL LY, IT WAS NOTED THAT THE RV LEAD EXHIBITED HIGH THRESHOLDS. 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 19107667 ↗
• MalfunctionDec 1, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE WARNING. THE LEAD REMAINS IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244650 ↗
• MalfunctionSep 28, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED APPROXIMATELY FIVE WEEKS POST IMPLANT THAT THE PATIENTS HEART RATE WOULD NOT ACHIEVE AROUND ONE HUNDRED AND EIGHTY, WHICH WAS COMMON BEFORE THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) EPICARDIAL LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM). THE IPG AND 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 17832217 ↗
• InjuryFeb 3, 2023Under-Sensing; Appropriate Device Problem Term/Code Not Available; Under-Sensing; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS. THE PATIENT THEN WENT INTO VENTRICULAR TACHYCARDIA (VT) WHERE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS 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; Sepsis; Tachycardia

  MAUDE report 16289992 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13666293 ↗
• InjuryJan 27, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) EPICARDIAL LEAD EXHIBITED HIGH THRESHOLDS AND FAILURE TO CAPTURE. THE LV 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 13371423 ↗
• InjuryDec 10, 2021Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) EPICARDIAL LEADS EXHIBITED INTERMITTENT LOSS OF CAPTURE AT HIGH OUTPUTS. THE LEADS 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 12974595 ↗
• MalfunctionAug 17, 2021Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED WARNINGS FOR LOW IMPEDANCE IN THE UNIPOLAR CONFIGURATION AND OVERSENSING . IT WAS ALSO REPORTED THAT THE  RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, HIGH V-V INTERVAL SENSING INTEGRITY COUNTER (SIC) COUNT AND CHRONIC HIGH THRESHOLDS. 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 12330202 ↗
• InjuryAug 3, 2021Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE. THE LEAD AND IPG WERE REPROGRAMMED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 12267433 ↗
• MalfunctionMay 27, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 11892716 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION AT NIGHT. THE LEFT ATRIAL LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 11601909 ↗
• MalfunctionMar 15, 2021Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 11488135 ↗
• MalfunctionNov 16, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT A WARNING WAS TRIGGERED FOR LOW PACING IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. UNDERSENSING AND FAR FIELD R-WAVE (FFRW) OVERSENSING WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD. 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 10842578 ↗
• InjuryNov 2, 2020Intermittent Capture; Fracture; High impedance; Over-Sensing; Intermittent Capture; Fracture; High impedance; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED.

  Patient problems: Dizziness

  MAUDE report 10769142 ↗
• MalfunctionOct 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD PIN EXHIBITED A BEND. THE LEAD WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10618987 ↗
• InjuryAug 5, 2020Failure to Capture; Fracture; High impedance; Capturing Problem; Failure to Capture; Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT THERE WAS A LEAD IMPEDANCE WARNING ON THE LEFT VENTRICULAR (LV) LEAD FOR HIGH UNDEFINED IMPEDANCE. A LEAD FRACTURE IS SUSPECTED. THE ALERTS WILL BE PROGRAMMED OFF AND A PLAN WILL BE DISCUSSED WITH THE PHYSICIAN. 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; No Consequences Or Impact To Patient

  MAUDE report 10369064 ↗
• MalfunctionApr 16, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR A LOW PACING IMPEDANCE. THE DEVICE WAS CHECKED AND THE IMPEDANCE MEASUREMENTS HAD RETURNED TO A NORMAL RANGE. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING DURING A BLANKING PERIOD AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DISPLAYED INVALID TREND DATA. THE LV LEAD, THE RA LEAD AND THE CRT-P REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9969800 ↗
• MalfunctionJul 23, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A WARNING FOR LOW IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815226 ↗