CapSure Sense® 407458 (UDI 00643169590526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00643169590526), received between Dec 9, 2016 and Sep 14, 2026 — classified as 35 injuries, 22 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (20 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. 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 50752151 ↗
• MalfunctionAug 25, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 22881914 ↗
• MalfunctionJul 22, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) AND HIGH THRESHOLDS. 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 22563418 ↗
• MalfunctionMar 27, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE DEVICE APPEARED TO BE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED A HIGH NUMBER OF SHORT VENTRICLE TO VENTRICLE (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 21705572 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED FOUR WEEKS POST IMPLANT DUE TO AN INFECTION. THE PATIENT WAS LATER IMPLANTED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21374454 ↗
• InjuryAug 8, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV 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 19937347 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 19604199 ↗
• MalfunctionMay 23, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 19379737 ↗
• InjuryJan 10, 2024Break; Break

  IT WAS REPORTED BY THE PATIENT THAT RIGHT VENTRICULAR (RV) LEAD HAD A BEND IN IT AND POSSIBLE LEAD DAMAGE WAS SUSPECTED. 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 18483619 ↗
• MalfunctionNov 27, 2023Electrical /Electronic Property Problem; Low impedance; Electrical /Electronic Property Problem; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH AND LOW IMPEDANCE WARNING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 18211415 ↗
• MalfunctionAug 22, 2023High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND VARIABLE 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 17594516 ↗
• InjuryJul 11, 2023Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED BIPOLAR THRESHOLD AND RISING BIPOLAR IMPEDANCE. THE RV 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 17296811 ↗
• MalfunctionSep 6, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 15361544 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND 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 14512797 ↗
• MalfunctionMar 19, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD 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 13825772 ↗
• InjuryMar 19, 2022High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD IMPEDANCE WARNING FOR HIGH AND UNDEFINED IMPEDANCE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED LOW IMPEDANCE. 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 13825743 ↗
• InjuryFeb 9, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING A PRE-PROCEDURAL DEVICE CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE AT MAXIMUM OUTPUT. IT WAS ALSO NOTED THAT THE PATIENT WENT INTO AN EXIT BLOCK. ATTEMPTS WERE MADE TO REPLACE THE RV LEAD, BUT THE PHYSICIAN HAD DIFFICULTLY GAINING ACCESS AND THE PATIENT COULD NOT LONGER TOLERATE LYING FLAT. THE PROCEDURE WAS ABANDONED AND REVISION PLANNED FOR A FUTURE DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Heart Block; Swelling/ Edema

  MAUDE report 13497483 ↗
• MalfunctionJul 7, 2021Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND CHRONIC LOW R-WAVES. 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 12126516 ↗
• InjuryJun 4, 2021Break; Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CUT BY ACCIDENT DURING OPEN HEART SURGERY. THE RA LEAD AND RV LEAD 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 11937971 ↗
• InjuryApr 22, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND HEART RATES DROPPING INTO THE 20S. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. 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; Syncope/Fainting

  MAUDE report 11705516 ↗
• InjuryMar 29, 2021High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING THRESHOLDS AND HIGH AND RISING IMPEDANCE. THE RV LEAD WAS CAPPED AND A NEW RV LEAD WAS PLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581358 ↗
• InjuryNov 25, 2020Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. REPROGRAMMING IS PLANNED. 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 10903587 ↗
• MalfunctionNov 12, 2020Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THERE WAS NO T-WAVE OVERSENSING (TWOS) AND NO INTERVENTION WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10827745 ↗
• MalfunctionAug 31, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT "ONE OF THE LEAD WIRES HAS COME LOOSE AND OVER STIMULATING" AND "I GET A SENSATION UP MY ARM, IT COMES AND GOES". THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 10471128 ↗
• MalfunctionJul 13, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT FAR FIELD R-WAVE (FFRW) OVERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD ON ELECTROGRAMS (EGM). BOTH LEADS 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 10264083 ↗