CAPSUREFIX® 5568-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00885074248592), received between Oct 6, 2016 and Aug 31, 2026 — classified as 1 death, 88 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (88 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 209 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead was capped and replaced. No patient complicat ions have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515984 ↗
• MalfunctionJun 22, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD ALSO EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 25587635 ↗
• MalfunctionMay 20, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED EPISODES. 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 25228787 ↗
• MalfunctionMay 15, 2026Under-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 25181187 ↗
• MalfunctionMay 1, 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 25054532 ↗
• MalfunctionApr 28, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND INAPPROPRIATE 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 25012101 ↗
• InjuryApr 23, 2026Failure to Capture; Under-Sensing; Decreased Sensitivity

  IT WAS NOTED THAT THE RA LEAD WAS REPROGRAMMED.

  Patient problems: Arrhythmia

  MAUDE report 24964724 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24770392 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, AND THE SOURCE OF INFECTION WAS STATED TO BE POSSIBLY FROM THE BLOOD IN ADDITION TO BACTEREMIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 24735187 ↗
• InjuryJan 22, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICAT IONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147119 ↗
• InjuryJan 14, 2026Break

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE. IT WAS ALSO NOTED THAT DURING OPEN HEART SURGERY THE PACING LEADS WERE CUT. T HE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 24067620 ↗
• MalfunctionDec 2, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE ON STORED EPISODES, LEADING TO ERRANT EPISODES BEING RECORDED BY THE DEVICE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC OUT-OF-RANGE, LOW PACING IMPEDANCE. 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 23696267 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23695134 ↗
• MalfunctionNov 24, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN FALSE DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AND INHIBITION OF ATRIAL PACING NOTED ON STORED ELECTROGRAMS (EGM). HISTORICALLY LOW P-WAVES WERE NOTED. ADDITIONALLY, IT WAS NOTED AT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. BOTH 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 23633721 ↗
• MalfunctionOct 31, 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 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 23433837 ↗
• MalfunctionOct 20, 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) EVENTS AT TIMES AND INAPPROPRIATE PACING 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 23334408 ↗
• MalfunctionSep 15, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING AND OVER SENSING. 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 23050258 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH SWELLING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22560055 ↗
• MalfunctionJul 17, 2025Under-Sensing; Capturing Problem; High Capture Threshold; Under-Sensing; Capturing Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A DROP IN SUPERIOR VENA CAVA (SVC) AND RV COIL IMPEDANCES, AND THE RA LEAD DISPLAYED AN INCREASE IN THRESHOLDS. IT WAS NOTED THAT BOTH CHANGES OCCURRED AROUND THE TIME THE PATIENT HAD A CORONARY ARTERY BYPASS GRAFT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528903 ↗
• MalfunctionJul 16, 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 AT/AF EVENT(S) AT TIMES AND INAPPROPRIATE PACING 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 22517228 ↗
• MalfunctionJul 1, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING THAT RESULTED IN AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT THAT DID NOT APPEAR TO BE TRUE. 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 22372698 ↗
• MalfunctionJun 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. 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 22306975 ↗
• MalfunctionJun 20, 2025Failure to Capture; Device Sensing Problem; High Capture Threshold; Failure to Capture; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS A POSSIBLE SENSING ISSUE ON THE RIGHT ATRIAL (RA) LEAD AND CAPTURE ISSUE AS CAPTURE COULD NOT BE CONFIRMED.  IT WAS ALSO REPORTED THERE WAS POSSIBLE SENSING ISSUE ON THE RIGHT VENTRICULAR (RV) LEAD. IT APPEARED THE RA LEAD PACE WAS SENSED ON THE VENTRICULAR CHANNEL POSSIBLY CAUSING PACING INHIBITION. IT WAS NOTED THE PATIENT FELT A ¿TWINGE¿ IN THEIR CHEST. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22299157 ↗
• InjuryJun 12, 2025Over-Sensing; Pacing Problem; Under-Sensing; Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. IN ADDITION, UNDERSENSING WAS OBSERVED DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN INAPPROPRIATE ATRIAL PACING. THE 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 22196828 ↗
• InjuryApr 17, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AT TIMES AND FAR FIELD R-WAVE (FFRW) OVERSENSING RESULTING IN INAPPROPRIATE MODE SWITCHING. IT WAS ALSO REPORTED THAT THERE WERE POSSIBLE HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS AND HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS NOTED. ADDITIONALLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) WITH 1:1 RETROGRADE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) VIA THE DEVICE FEATURE THAT USES PATTERN AND RATE ANALYSIS TO DISCRIMINATE BETWEEN SVT AND TRUE VENTRICULAR TACHYARRHYTHMIAS. IT WAS ALSO PREVIOUSLY OBSERVED THAT THE CRT-D INAPPROPRIATELY WITHHELD THERAPY FOR VT DETECTED AS SVT VIA THE DEVICE FEATURE DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF AN SVT ORIGIN. THE RA, RV AND LV LEADS AND DEVICE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859026 ↗