CapSure Sense® 457445Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 00643169410824), received between Dec 9, 2016 and Aug 31, 2026 — classified as 77 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (97 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 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Under-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521161 ↗
• InjuryMay 12, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE. 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 25146651 ↗
• 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 24814977 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24517899 ↗
• MalfunctionNov 17, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN BLANKING AT TIMES WHICH TRIGGERED DEVICE CLASSIFIED TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AND POTENTIAL INAPPROPRIATE ATRIAL PACING. 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 23570382 ↗
• MalfunctionOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONIC UNDEFINED HIGH IMPEDANCE. THE RA LEAD REMAINS 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 23355422 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing; Electrical /Electronic Property Problem; Pacing Problem; 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 AND ALSO RESULTED IN INAPPROPRIATE ATRIAL PACING AND DEVICE CLASSIFIED FALSE DETECTION OF SOME VENTRICULAR TACHYCARDIA (VT) EPISODES. IT WAS ALSO REPORTED THAT THE LEAD EXHIBITED ATRIAL LEAD POSITION CHECK (ALPC) FAILURE. 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 23277140 ↗
• InjurySep 18, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON VENTRICULAR TACHYCARDIA (VT) MONITOR EPISODES AND AN INCREASE IN THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN FALSE CLASSIFICATION OF EVENTS AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE PATIENT WAS EXTERNALLY SHOCKED AND PACED. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 23082726 ↗
• MalfunctionSep 17, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE, INAPPROPRIATE SENSING, NOISE, OVERSENSING AND SUSPECTED FRACTURE. 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 23070769 ↗
• InjurySep 10, 2025Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDEFINED IMPEDANCE, A POLARITY SWITCH, AND NO CAPTURE. A FRACTURE WAS CONFIRMED. 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 23013434 ↗
• InjuryAug 18, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD UNDERSENSING WAS NOTED ON STORED ELECTROGRAMS (EGM). THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835511 ↗
• MalfunctionAug 15, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING CAUSING INAPPROPRIATE ATRIAL PACING. 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 22820937 ↗
• MalfunctionJul 21, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. IT WAS ALSO REPORTED THAT THE UNDERSENSING RESULTED IN INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553422 ↗
• MalfunctionJun 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED EGM. THE LEADS 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 22327328 ↗
• MalfunctionMay 29, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT AN ATRIAL UNDEFINED HIGH BIPOLAR LEAD IMPEDANCE WARNING OF LESS THAN 200 OHMS OCCURRED ON (B)(6) 2025, AND THE DEVICE APPEARED TO BE OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD NOTED ON A STORED EPISODE ELECTROGRAM. CURRENT MEASUREMENTS WERE NOTED TO BE WITHIN THE EXPECTED RANGE. 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 22104638 ↗
• MalfunctionMay 2, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM). 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 21948243 ↗
• MalfunctionApr 15, 2025Under-Sensing; Decreased Sensitivity; High Capture Threshold; Over-Sensing; Under-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE CAPTURE ISSUE AND HIGH THRESHOLDS. HIGH THRESHOLDS WERE ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE RV 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 21838463 ↗
• MalfunctionMar 5, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. 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 21525597 ↗
• MalfunctionFeb 18, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION 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 21402848 ↗
• MalfunctionFeb 12, 2025Pacing Problem; Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS ALONG WITH UNDERSENSING NOTED DURING ATRIAL TACHYCARDIA/AT RIAL FIBRILLATION (AT/AF). 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; Palpitations

  MAUDE report 21365024 ↗
• InjuryJan 20, 2025Failure to Capture; Fracture; Under-Sensing; Failure to Capture; Fracture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED AND EXHIBITED NO ATRIAL CAPTURE AND NO 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 21189293 ↗
• MalfunctionJan 15, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING, CHRONIC LOW R-WAVES AND SHORT V-V INTERVALS. IT WAS FUR THER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. BOTH RA AND 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 21158905 ↗
• MalfunctionJan 14, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. 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 21150366 ↗
• MalfunctionDec 3, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 20835574 ↗
• MalfunctionNov 1, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. 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 20585568 ↗