Capsure® EPI 4965-15 (UDI 00681490116336)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00681490116336), received between Jan 25, 2017 and Apr 23, 2026 — classified as 55 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 68 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE, HIGH THRESHOLDS, LOSS OF CAPTURE AND TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE. THE RIGHT ATRIAL (RA) LEAD WAS NOTED TO BE UNUSABLE. THE RA LEAD WAS PROGRAMMED OFF, CAPPED AND LATER EXPLANTED AND REPLACED. THE RV 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 24963646 ↗
• InjuryJun 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEADS EXHIBITED NO CAPTURE. THE LEADS WERE INACTIVATED AND REMAIN 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 22144280 ↗
• InjuryJun 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEADS EXHIBITED NO CAPTURE. THE LEADS WERE INACTIVATED AND REMAIN 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 22144255 ↗
• InjuryMay 2, 2025Failure to Capture; Electrical /Electronic Property Problem; High impedance; Failure to Capture; Electrical /Electronic Property Problem; High impedance

  IT WAS FURTHER REPORTED THAT THE HIGH OUT OF RANGE IMPEDANCE ON THE RV LEAD OCCURRED PRIOR TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947971 ↗
• MalfunctionMay 2, 2025Electrical /Electronic Property Problem; Impedance Problem; Electrical /Electronic Property Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES, NO CAPTURE AND A POLARITY SWITCH. A LEAD IMPEDANCE WARNING AND POLARITY SWITCH WAS ALSO OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THAT THE RA LEAD FAILED AN ATRIAL LEAD POSITION CHECK. THE RV LEAD WAS CAPPED AND REPLACED. 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 21947964 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD WAS CAPPED AND REMAINS IN THE PATIENT. THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO EXHIBITED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 21571951 ↗
• MalfunctionJun 21, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD WARNING. THE IMPEDANCE WAS NOTED TO BE CHRONICALLY LOW. 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 19582269 ↗
• MalfunctionApr 24, 2024Failure to Capture; Fracture; Failure to Capture; Fracture

  IT WAS REPORTED THAT THE DURING A GENERATOR CHANGE OUT WHEN ATTEMPTING TO CONNECT THE RIGHT ATRIAL (RA) LEAD TO THE REPLACEMENT IMPLANTABLE PULSE GENERATOR (IPG) NO CLICKS WERE AUDIBLE AND THE LEAD WAS EASILY PULLED OUT OF THE HEADER. THE LEAD WAS TAKEN OUT OF THE HEADER, AND THE SET SCREW WAS VISUALLY CONFIRMED TO NOT BE OBSTRUCTING THE PORT. THE LEAD WAS THEN RE-INSERTED INTO THE HEADER WHILE THE WRENCH WAS HELD IN PLACE TO VENT ANY TRAPPED AIR. AGAIN, NO WRENCH CLICKS WERE HEARD AND THE LEAD WAS NOT SECURED. THE IPG WAS REMOVED AND REPLACED. WHEN WRENCHING THE RA LEAD INTO THE REPLACEMENT IPG WRENCH CLICKS WERE HEARD IMMEDIATELY AND THE LEAD WAS SECURED. A VISIBLE FRACTURE WAS OBSERVED AT THE PIN PLUG JUNCTION TO THE MAIN LEAD BODY THAT HAD BEEN SUSPECTED DUE TO NO CAPTURE OF THE ATRIAL LEAD. THE IPG WAS ATTEMPTED NOT USED, REMOVED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE FOR SENSING PURPOSES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173886 ↗
• InjuryMar 7, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD HAD A SUSPECTED FRACTURE. THE RA 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 18862675 ↗
• InjuryNov 22, 2023High 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 COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18189696 ↗
• InjuryJan 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE. THE RV 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 16110898 ↗
• InjuryNov 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE. THE RA AND RV LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 15850434 ↗
• InjurySep 14, 2022Failure to Capture; Electrical /Electronic Property Problem; High impedance; Failure to Capture; Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION/ABDOMINAL STIMULATION AND NERVE STIMULATION. IT WAS ALSO REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE IN BIPOLAR CONFIGURATION AND A POLARITY SWITCH. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED NO CAPTURE. THE RA 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; Undesired Nerve Stimulation

  MAUDE report 15416410 ↗
• InjuryMay 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXHIBITED PRESYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CONFIRMED FRACTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope

  MAUDE report 14266042 ↗
• InjuryFeb 11, 2022Fracture; High impedance; Pacing Problem; Under-Sensing; Device Sensing Problem; Fracture; High impedance; Pacing Problem; Under-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT SENSING LEADING TO LEAD FAILURE, RESULTING IN THE IMPLANTABLE PULSE GENERATOR (IPG) BEING REPROGRAMMED TO MONITOR AND SENSE ONLY MODE. IT WAS ALSO NOTED THAT THE IPG DID NOT RECORD MARKERS ON ELECTROGRAMS (EGM) CORRECTLY. THE RV LEAD AND IPG 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 13514295 ↗
• InjuryNov 23, 2021Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Low impedance; High Capture Threshold; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, LOW IMPEDANCE, HIGH THRESHOLDS, NO CAPTURE, POLARITY SWITCH AND A POSSIBLE FRACTURE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, NO CAPTURE, HIGH/UNDEFINED IMPEDANCE, POLARITY SWITCH AND POSSIBLE FRACTURE. BOTH HE RA AND RV 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 12859253 ↗
• InjurySep 3, 2021High impedance; Pacing Problem; High impedance; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE RA LEAD AND RV LEAD WERE EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420579 ↗
• InjuryJun 17, 2021Electrical /Electronic Property Problem; Low impedance; High Capture Threshold; Electrical /Electronic Property Problem; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, ATRIAL LEAD POSITION CHECK FAIL AND LOW UNIPOLAR IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW UNIPOLAR IMPEDANCE, HIGH THRESHOLDS, SHORT V-V INTERVALS. 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 12016932 ↗
• InjuryJun 17, 2021Over-Sensing; Low impedance; High Capture Threshold; Over-Sensing; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, ATRIAL LEAD POSITION CHECK FAIL AND LOW UNIPOLAR IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW UNIPOLAR IMPEDANCE, HIGH THRESHOLDS, SHORT V-V INTERVALS. 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 12016916 ↗
• InjuryJun 14, 2021Fracture; Under-Sensing; Fracture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A FRACTURE AND NO SENSING. 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 11990006 ↗
• InjuryJun 1, 2021Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND NO CAPTURE AT MAX OUTPUTS. THE LEAD WAS REPROGRAMMED AND THEN 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 11911833 ↗
• MalfunctionMay 31, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW UNIPOLAR LEAD IMPEDANCE WARNING. 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 11906312 ↗
• InjuryFeb 25, 2021Intermittent Capture; Failure to Capture; Intermittent Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SEIZURE-LIKE SYMPTOMS AND SIGNIFICANT BRADYCARDIA. THEY ADMINISTERED MEDICATION TO THE PATIENT WHICH THEY DID NOT TOLERATE VERY WELL AND WAS VOMITING. IT WAS NOTED THAT THEIR PACEMAKER WAS NOT CAPTURING AND IT WAS IDENTIFIED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE EVEN AT THE DEVICES MAXIMUM PROGRAMMABLE OUTPUTS. SOME INTERMITTENT CAPTURE WAS ALSO OBSERVED WHEN THE PATIENT WAS LYING ON THEIR RIGHT SIDE. THE RIGHT VENTRICULAR (RV) LEAD AND THE REMAINING SYSTEM WAS PROGRAMMED OFF AND INACTIVATED AND WILL BE REMOVED AT A LATER DATE. A NEW IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Convulsion/Seizure; Vomiting

  MAUDE report 11377242 ↗
• InjuryOct 9, 2020Break; High Capture Threshold; Break; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND "INSULATION STRIPPED WHEN TAKEN OUT OF HEADER". THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10654738 ↗
• InjuryAug 26, 2020Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FRACTURE, HIGH IMPEDANCE, LEAD IMPEDANCE WARNING, NO CAPTURE AND UNDERSENSING. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452926 ↗