CapSure Sense® 407458 (UDI 00643169411081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169411081), received between Dec 9, 2016 and Jul 1, 2026 — classified as 28 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (11 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE LOW IMPEDANCE AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ST ORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS, LACK OF DETECTION OF AT/AF, AND INAPPROPRIATE PACING. IT WAS ALSO NOTED THAT THERE WERE LOW AMPLITUDE P WAVES. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25678363 ↗
• InjuryApr 22, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND 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 24950841 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VEGETATION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. A TEMPORARY IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24814973 ↗
• InjuryAug 13, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MAY HAVE EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED THRESHOLDS. THE IPG WAS REMOVED AND REPLACED AND 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 22792152 ↗
• 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 A SYSTEMIC INFECTION. THE SOURCE OF THE INFECTION IS REPORTED TO BE THE LEG, WHICH WAS AMPUTATED. VEGETATION WAS ALSO NOTED ON THE TIP OF THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20520427 ↗
• MalfunctionAug 15, 2024Device Sensing Problem; Unstable Capture Threshold; Device Sensing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE THRESHOLDS AND R WAVE MEASUREMENTS. THE RA LEAD AND RV LEAD REMAIN IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991334 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16917442 ↗
• MalfunctionNov 23, 2022Under-Sensing; Under-Sensing

  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 15850610 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS EROSION AT THE IMPLANT SITE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED 6 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 15775371 ↗
• InjuryAug 10, 2022Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE AT MAXIMUM OUTPUTS. 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 15201631 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT CULTURES WERE TAKEN AND NO BACTERIA WAS IDENTIFIED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 12374962 ↗
• InjuryApr 26, 2021Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE.

  Patient problems: Chest Pain; Syncope/Fainting

  MAUDE report 11722785 ↗
• InjuryApr 23, 2021Intermittent Capture; Failure to Capture; Intermittent Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT HAD A SUSTAINED VENTRICULAR TACHYCARDIA AND ON THE SAME WENT INTO CARDIAC ARREST, WITH POSSIBLE EXTERNAL DEFIBRILLATION ADMINISTERED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE NON-CAPTURE AND ALSO POSSIBLE INTERMITTENT CAPTURE, ON STORED ELECTROGRAMS (EGMS). THE PATIENT WAS RUSHED TO THE CATHETER LABORATORY, WHERE AN UNSPECIFIED SURGICAL INTERVENTION WAS CARRIED OUT. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Tachycardia

  MAUDE report 11715442 ↗
• MalfunctionNov 16, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO PACING SPIKES. IT WAS NOTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 10842799 ↗
• InjuryOct 28, 2020High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND HIGH IMPEDANCE. THE 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 10746203 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED DUE TO VALVE VEGETATION. THE IPG SYSTEM WAS REPLACED APPROXIMATELY TWELVE DAYS POST EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10194969 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUBCLAVIAN STENOSIS AT THE POINT OF ENTRY OF EXISTING LEADS. THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLD AND PREMATURE BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS OBSERVED. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE, THE RA LEAD WAS REPROGRAMMED AND THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10184445 ↗
• MalfunctionJan 7, 2020Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS CARDIOVERTED OUT OF ATRIAL FIBRILLATION (AF). ATRIAL SENSING RETURNED TO SUFFICIENT LEVELS AND THE RIGHT VENTRICULAR (RV) LEAD PARAMETERS WERE OPERATING NORMALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9556762 ↗
• InjuryNov 7, 2019Failure to Capture; Fracture; High impedance; Under-Sensing; Failure to Capture; Fracture; High impedance; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, LOSS OF SENSING, LOSS OF CAPTURE AND WAS FOUND TO BE FRACTURED. THE TERMINAL SEGMENT OF THE LEAD WAS CUT AND THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9289368 ↗
• InjuryMay 14, 2019Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  THE PATIENT PRESENTED TO THE CLINIC WITH WEAKNESS, DIZZINESS AND SHORTNESS OF BREATH. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND LOSS OF CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea; Weakness

  MAUDE report 8607015 ↗
• InjuryJan 9, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD THRESHOLD WAS HIGH. THE OUTPUT WAS REPROGRAMMED TO PROVIDE A BETTER SAFETY MARGIN AND THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL LEAD HAD POSSIBLE INTERMITTENT UNDERSENSING, AS NOTED ON PRESENTING AND STORED ELECTROGRAMS (EGM.) 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 8231073 ↗
• InjuryDec 18, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS ATRIAL UNDERSENSING NOTED DURING EPISODES AND ON THE CURRENT ELECTROGRAM (EGM), ALONG WITH ONE ISOLATED POSSIBLE UNDERSENSED QRS COMPLEX. THE PATIENT WAS TO BE ADMITTED TO A HOSPITAL. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174856 ↗
• MalfunctionSep 26, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND DIZZINESS. OVERSESNSING ON THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 7911978 ↗
• MalfunctionJul 10, 2018Over-Sensing; Capturing Problem; High Capture Threshold; Capturing Problem

  IT WAS REPORTED THAT THE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED AND HAD BEEN HIGH. THERE WERE ALSO POSSIBLE FAR FIELD R-WAVES (FFRW) AND POSSIBLE ATRIAL OVERSENSING NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS EXPLANTED AND REPLACED. THE RV 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 7673830 ↗
• InjuryJul 6, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. 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 7668199 ↗