CapSure Sense® 407452 (UDI 00643169411074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169411074), received between Dec 9, 2016 and Oct 31, 2025 — classified as 25 injuries, 10 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. 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.

• InjuryOct 31, 2025High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  THE LEAD EXHIBITED HIGH IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436998 ↗
• InjuryOct 2, 2024High 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20352185 ↗
• InjuryApr 25, 2024Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISING THRESHOLDS THAT WERE NOW ELEVATED. THE RV LEAD WAS REPOSITIONED AND PLACED IN THE LEFT VENTRICULAR (LV) PORT AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179440 ↗
• MalfunctionApr 22, 2024Under-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 19152076 ↗
• MalfunctionFeb 14, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WHICH IS CAUSING DEVICE CLASSIFIED FALSE TERMINATION OF  EPISODES. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE UNDERSENSING ON ELECTROGRAMS (EGM). THE RA AND RV 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 18702204 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17622306 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC BACTEREMIA INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITH THE IPG BEING USED AS A TEMPORARY EXTERNAL PACEMAKER UNTIL THE INFECTION CLEARS. A REPLACEMENT RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED AND CONNECTED TO THE EXTERNAL IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 17395526 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BACTEREMIA, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUSPECTED TO BE INFECTED. THE IPG SYSTEM WAS EXPLANTED, AND A NEW SYSTEM WAS IMPLANTED AT A LATER DATE. DURING THE LATER IMPLANT PROCEDURE, A NEW RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED, BUT EXHIBITED LOW IMPEDANCES. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 16431631 ↗
• MalfunctionSep 29, 2022Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER-SENSING AND INCREASED 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 15501354 ↗
• InjuryAug 11, 2022Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE FRACTURE AND WAS NOT CAPTURING THE RV AT MAX OUTPUT. IT WAS REPORTED THAT THE RV LEAD EXHIBITED HIGH 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

  MAUDE report 15208056 ↗
• InjuryJul 25, 2022Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH LOSS OF CONSCIOUSNESS, ASYSTOLE AND HEART BLOCK. AN ELECTROCARDIOGRAM (ECG) SHOWED INTERMITTENT LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD WITH PACING SPIKES NOTED AND IT WAS NOTED THAT THERE WAS STABLE IMPEDANCES, STABLE LEAD TRENDS, AND LACK OF ALERTS. SUSPECTED PACING ISSUE ON THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUSPECTED. THE RV LEAD WAS CAPPED AND THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Heart Block; Loss of consciousness

  MAUDE report 15092404 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTABLE PULSE GENERATOR (IPG) ERODED THROUGH THE SKIN. THE IPG SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 14873451 ↗
• MalfunctionMay 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT THAT THEIR "WIRES" CAME "LOOSE" BEFORE AND THEY CAME "LOOSE" AGAIN. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS BOTH 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 14433481 ↗
• MalfunctionMar 15, 2022Over-Sensing; Over-Sensing

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

  MAUDE report 13768375 ↗
• MalfunctionSep 10, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE OVERSENSING, NON-CAPTURE AND DROPPED TO THE ATRIUM FLOOR, SUGGESTING POTENTIAL DISLODGEMENT. BOTH THE RV LEAD 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 12454223 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWOLLEN ARM.  VENOGRAM DISPLAYED COMPLETE OCCLUSION.  THE COMPLETE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion; Swelling/ Edema

  MAUDE report 12286257 ↗
• InjuryApr 13, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS AND OCCASIONAL LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AT MAXIMUM OUTPUTS. IT WAS FURTHER NOTED THAT THE PATIENT WAS EXPERIENCING DIZZINESS. THE LV LEAD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 11657534 ↗
• InjuryJan 14, 2021Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE IN IMPEDANCE AND INCREASE OF 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 11169289 ↗
• MalfunctionOct 6, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT OVERSENSING ON STORED ELECTROGRAMS (EGM). THE RV LEAD RE MAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10633743 ↗
• InjuryMay 5, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED DURING A ROUTINE UPGRADE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10024842 ↗
• InjuryApr 1, 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 Known Impact Or Consequence To Patient

  MAUDE report 9909339 ↗
• InjuryDec 24, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND THAT BRADYCARDIA WAS SEEN ON SURFACE ELECTROGRAMS (EGM). IT WAS NOTED THAT CAPTURE COULD NOT BE CONFIRMED ON THE RIGHT VENTRICULAR (RV) LEAD ON STORED ELECTROGRAMS (EGM). THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9515804 ↗
• MalfunctionNov 13, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THERE WAS POTENTIAL NOISE RECORDED ON THE RIGHT VENTRICULAR (RV) LEAD. 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 9314147 ↗
• MalfunctionOct 17, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SYMPTOMS OF CHEST DISCOMFORT AND RESPIRATORY DISTRESS. THE PRESENTING ELECTROCARDIOGRAM SHOWS ONE VENTRICULAR UNDERSENSING DROP BEAT ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Respiratory Distress

  MAUDE report 7974572 ↗
• InjuryMay 10, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYNCOPE. IT WAS OBSERVED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH NUMBER OF V-V INTERVALS ON THE SENSING INTEGRITY COUNTER (SIC). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 7504749 ↗