CAPSURE® SENSE 407458Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00885074200668), received between Jun 8, 2013 and May 29, 2026 — classified as 3 deaths, 104 injuries, 44 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (44 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING THRESHOLDS AND 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 25328821 ↗
• MalfunctionMay 20, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVERPACING AND A FAILURE TO MEET DEVICE CLASSIFIED EPISODE DETECTION CRITERIA. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25230434 ↗
• MalfunctionMay 15, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. HIGH RV THRESHOLDS WERE ALSO NOTED. 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 25181457 ↗
• MalfunctionMar 30, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED UNDER SENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 24728323 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSSIBLE DEVICE POCKET INFECTION. THE PATIENT EXPERIENCED SWELLING AND HAD WOUND DEHISCENCE. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 24619900 ↗
• MalfunctionFeb 18, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING WHICH RESULTED IN INAPPROPRIATE PACING. THE RV LEAD REM AINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375450 ↗
• InjuryJan 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219544 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA AND EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Erosion

  MAUDE report 23906063 ↗
• InjuryDec 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A "MECHANICAL BREAKDOWN OF CARDIAC ELE". THE LEFT VENTRICULAR (LV) LEAD, RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825571 ↗
• InjuryDec 11, 2025Signal Artifact/Noise; Intermittent Capture; Failure to Capture; Fracture; Signal Artifact/Noise; Intermittent Capture; Failure to Capture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND WAS FRACTURED. 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 23776813 ↗
• MalfunctionSep 18, 2025Fracture; Impedance Problem; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE AND HAD TRIGGERED AN ALERT FOR RISING 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 23082597 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. FATIGUE, FEVER AND PUS AT THE POCKET SITE WERE OBSERVED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue; Fever; Unspecified Infection

  MAUDE report 22991311 ↗
• InjuryJun 12, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. 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 22192533 ↗
• InjuryJun 6, 2025Failure 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, NO CAPTURE AND THE LEAD WAS NOT SENSING. 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 22156813 ↗
• InjuryApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT DUE TO INFECTION. THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD WERE PARTIALLY EXPLANTED AND CAPPED DUE TO THE SUBCLAVIAN VEIN BEING OCCLUDED AND THE POCKET WAS HEAVILY CALCIFIED AND THE LEADS BROKE ON EXTRACTION ATTEMPT. THE LEADS WERE CAPPED. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Obstruction/Occlusion

  MAUDE report 21907419 ↗
• InjuryApr 17, 2025Intermittent Capture; Capturing Problem; Intermittent Capture; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS AND INTERMITTENT CAPTURE. 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 21854403 ↗
• MalfunctionApr 2, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD AND POSSIBLE UNDERSENSING ON MONITORED VENTRICULAR TACHYCARDIA (VT) EPISODE. 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 21751647 ↗
• MalfunctionFeb 7, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A SPIKE IN THE RIGHT VENTRICULAR (RV) LEAD BIPOLAR AND UNIPOLAR LEAD IMPEDANCE TRENDS. THE ISSUE APPEARED TO OCCUR ON (B)(6) 2025. 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 21330817 ↗
• InjuryJan 8, 2025High 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 21100710 ↗
• MalfunctionJan 6, 2025Electrical /Electronic Property Problem; Over-Sensing; Low impedance; Electrical /Electronic Property Problem; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW UNIPOLAR IMPEDANCE AND POLARITY SWITCH. THE RV LEAD ALSO EXHIBITED SHORT V-V INTERVALS. 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 21078828 ↗
• InjuryNov 4, 2024Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT DURING THE IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT PROCEDURE, HIGH IMPEDANCE AND NO CAPTURE WAS NOTED ON THE VENTRICULAR CHANNEL. THE RIGHT VENTRICULAR (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 20597974 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, EROSION, PAIN, PURULENT DISCHARGE AND REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 20521048 ↗
• InjuryOct 21, 2024Intermittent Capture; Capturing Problem; Unstable Capture Threshold; Intermittent Capture; Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE, BRADYCARDIA AND DIZZINESS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS, UNSTABLE THRESHOLDS AND INTERMITTENT CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Syncope/Fainting

  MAUDE report 20491127 ↗
• InjurySep 19, 2024Intermittent Capture; Failure to Capture; Unstable Capture Threshold; Intermittent Capture; Failure to Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE AS WELL AS LOSS OF CAPTURE. THE RV LEAD ALSO EXHIBITED VARYING THRESHOLDS WHEN POSITIONAL THRESHOLD TEST WERE PERFORMED. THE PATIENT ALSO EXPERIENCED BRADYCARDIA AND DIZZINESS. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 20257261 ↗
• MalfunctionSep 2, 2024High 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 20116683 ↗