CapSure Sense® 457453Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00643169410831), received between Dec 9, 2016 and Nov 17, 2025 — classified as 1 death, 55 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (42 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. THE RA 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 23566873 ↗
• InjuryOct 30, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A SPIKE IN IMPEDANCE AND HIGH UNDEFINED ATRIAL IMPEDANCE. THE RA LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423270 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 23359284 ↗
• MalfunctionJul 28, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. 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 22628821 ↗
• InjuryJan 29, 2025Signal Artifact/Noise; Capturing Problem; High Capture Threshold; Signal Artifact/Noise; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH RV THRESHOLDS AS WELL AS NOISE. IN ADDITION, IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING AND HIGH ATRIAL THRESHOLDS AS WELL AS NOISE. THE RV LEAD AND RA LEAD WERE REPROGRAMMED AND LATER BOTH 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 21267392 ↗
• MalfunctionNov 6, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOTED ON STORED ELECTROGRAMS (EGM). THIS DID NOT APPEAR TO BE A TRUE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT. 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 20621189 ↗
• MalfunctionJun 25, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD CAUSING FALSE DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS. 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 19604269 ↗
• MalfunctionJun 7, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON SOME STORED ELECTROGRAMS (EGM). THE RA 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 19492142 ↗
• MalfunctionMar 6, 2024Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem; Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A POSSIBLE FRACTURE. THE RA LEAD EXHIBITED A SUDDEN RISE IN BIPOLAR IMPEDANCE, HIGH BIPOLAR IMPEDANCE AND A SUBSEQUENT POLARITY SWITCH. THE HIGH BIPOLAR IMPEDANCE RESULTED IN BEING UNABLE TO PROGRAM MAGNETIC RESONANCE IMAGING (MRI) SURE SCAN MODE AND INABILITY TO DO THE MRI SCAN. THE RA 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 18844287 ↗
• MalfunctionJan 29, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AT DEVICE CLASSIFIED TERMINATION OF EVENTS. THE RA 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 18595170 ↗
• InjuryDec 8, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF), ATRIAL FLUTTER AND WAS UNABLE TO MAINTAIN AV SYNCHRONY. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING. THE RA WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Atrial Flutter

  MAUDE report 18290030 ↗
• MalfunctionNov 22, 2023Low impedance; Low impedance

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A CERVICAL SPINE ABLATION PROCEDURE DONE ON THE DAY OF THE LEAD WARNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18189423 ↗
• MalfunctionNov 14, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF), NOT AFFECTING MODE SWITCH. 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 18128851 ↗
• InjurySep 14, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. A LEAD FRACTURE WAS SUSPECTED. 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 17744156 ↗
• InjurySep 5, 2023Failure to Capture; Pacing Problem; Under-Sensing; Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED.

  Patient problems: Tachycardia

  MAUDE report 17681910 ↗
• MalfunctionAug 22, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE RA 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 17594511 ↗
• InjuryAug 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BYPASS SURGERY THE PATIENT EXPERIENCED BRADYCARDIA. THE RIGHT ATRIAL (RA) LEAD WAS NOTED TO HAVE DISLODGED DURING THE SURGERY. THE RA LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17555282 ↗
• MalfunctionAug 9, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL UNDERSENSING OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ON STORED ELECTROGRAMS (EGM) WAS OBSERVED. THE RA 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 17487662 ↗
• MalfunctionJul 24, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM) WITH THE DEVICE STAYING MODE SWITCHED. THE RA 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 17376692 ↗
• MalfunctionJun 22, 2023Failure to Capture; Pacing Problem; Device Sensing Problem; Unstable Capture Threshold; Failure to Capture; Pacing Problem; Device Sensing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS POSSIBLY PACING BELOW THE LOWER RATE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE AND POSSIBLE CHANGE IN P WAVES AND THRESHOLDS. IT WAS ALSO REPORTED THAT THE RA LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE NOT PACING. THE IPG SYSTEM 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 17180437 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16700439 ↗
• InjuryJan 20, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA 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 16213645 ↗
• MalfunctionDec 27, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING RARE UNDERSENSING WITH CHRONIC/PERSISTENT ATRIAL TACHYCARDIA/ATRIAL F IBRILLATION (AT/AF). THE RA 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 16050488 ↗
• InjuryNov 15, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING IMPLANT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RA LEAD CONTINUED TO EXHIBIT HIGH THRESHOLDS POST IMPLANT AND LOSS OF CAPTURE ON THE RA LEAD WAS SUSPECTED. THE RA LEAD WAS REPROGRAMMED. IT WAS ALSO REPORTED THAT THE RA LEAD CONTINUED TO EXHIBIT HIGH THRESHOLDS AND LOSS OF CAPTURE. THE RA LEAD WAS CAPPED AND REPLACED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797716 ↗
• MalfunctionSep 5, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ON STORED ELECTROGRAMS (EGM) WAS OBSERVED, RESULTING IN FALSE TERMINATIONS OF AT/AF EPISODES. THE RA 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 15355439 ↗