CapSure Sense® 407452 (UDI 00643169590519)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00643169590519), received between Dec 9, 2016 and Jan 15, 2026 — classified as 2 deaths, 47 injuries, 23 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (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. 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING. 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 24077837 ↗
• DeathDec 19, 2025Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF), AND STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON CURRENT ELECTROGRAMS (EGM) AND LOSS OF CAPTURE. THE PATIENT EXPERIENCED A CARDIAC ARREST AND PASSED AWAY.

  Patient problems: Cardiac Arrest

  MAUDE report 23852821 ↗
• InjurySep 18, 2025Under-Sensing; Capturing Problem; Under-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON VENTRICULAR TACHYCARDIA (VT) MONITOR EPISODES AND AN INCREASE IN THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN FALSE CLASSIFICATION OF EVENTS AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE PATIENT WAS EXTERNALLY SHOCKED AND PACED. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 23082734 ↗
• InjurySep 18, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NO CAPTURE AND HIGH IMPEDANCE. THE LEAD WAS REPROGRAMMED AND REMAINS 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 23081587 ↗
• MalfunctionJun 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED EGM. 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 22327327 ↗
• MalfunctionJun 12, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON SOME ELECTROGRAMS (EGM). 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 22192555 ↗
• MalfunctionMay 13, 2025Decreased Sensitivity; Impedance Problem; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED DECREASED LEAD IMPEDANCES. IT WAS NOTED THE RV LEAD EXHIBITED DIMINISHED SENSING ALSO. 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 22009912 ↗
• MalfunctionMay 1, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING NOTED ON STORED VENTRICULAR ELECTROGRAMS (EGM) DURING POSSIBLE VENTRICULAR ARRHYTHMIAS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISPLAYED OVERSENSING NOTED ON CURRENT ATRIAL EGM. BOTH 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 21941010 ↗
• MalfunctionApr 22, 2025Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT RV LEAD EXHIBITED UNDERSENSED VENTRICULAR BEAT ON STORED EGM, THAT DID NOT APPEAR TO BE CURRENTLY AFFECTING DEVICE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880542 ↗
• MalfunctionApr 15, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE CAPTURE ISSUE AND HIGH THRESHOLDS. HIGH THRESHOLDS WERE ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE RV AND RA 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 21838457 ↗
• MalfunctionMar 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. 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 21570239 ↗
• MalfunctionNov 20, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE UNDER SENSING. 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 20734570 ↗
• MalfunctionSep 13, 2024Electrical /Electronic Property Problem; High impedance; Impedance Problem; Electrical /Electronic Property Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING HIGH IMPEDANCE WITH POLARITY SWITCH TRIGGERED. 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 20212384 ↗
• InjuryNov 13, 2023Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN.

  Patient problems: Chest Pain; Syncope/Fainting

  MAUDE report 18117950 ↗
• InjurySep 11, 2023Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED AND THAT THE PATIENT'S SYMPTOMS OF ECTOPY ON THE MONITOR AND SHORTNESS OF BREATH WERE NOT LINKED TO THE RV LEAD UNDERSENSING.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 17717938 ↗
• MalfunctionFeb 27, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND INCREASING THRESHOLD. THE CURRENT OUTPUT IS TWO TIMES THE THRESHOLD. 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 16442077 ↗
• InjuryFeb 20, 2023Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE, A CONFIRMED FRACTURE AND HIGH UNDEFINED IMPEDANCE. 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; Obstruction/Occlusion

  MAUDE report 16403467 ↗
• MalfunctionSep 12, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS SUSPECTED NOISE NOTED ON ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WITH OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD WHICH WERE CHRONIC PER PREVIOUS HISTORICAL RANGES. 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 15401737 ↗
• InjuryMar 23, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED LOSS OF CAPTURE ON TELEMETRY. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 13856963 ↗
• MalfunctionDec 10, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE ON TELEMETRY. 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 10982559 ↗
• InjuryNov 30, 2020High 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 10919421 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION OCCURRED IN THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET. ANTIBIOTICS WERE ADMINISTERED. THE SYSTEM WAS EXPLANTED AND WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10834638 ↗
• MalfunctionNov 13, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVER-SENSING. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT VENTRICLE-VENTRICLE (V-V) INTERVALS DUE TO SENSING INTEGRITY COUNTER (SIC). THE RA LEAD AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10834380 ↗
• InjuryJul 3, 2019High Capture Threshold; High Capture Threshold

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8757471 ↗
• MalfunctionMar 22, 2019Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD, AND CAPTURE COULD NOT BE CONFIRMED. 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 8443669 ↗