Capsurefix® DXAC/DSP 5568-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00613994776822), received between Dec 9, 2016 and Aug 26, 2026 — classified as 4 deaths, 83 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (64 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 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Failure to Capture; High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457146 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) 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 50451274 ↗
• MalfunctionAug 25, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events which at times resulted in unnecessary 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 50432875 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297100 ↗
• MalfunctionJun 26, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED EPISODES, RESULTING IN NON-PHYSIOLOGIC INTERVALS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH THRESHOLDS. THE MEASUREMENT WAS NOTED TO BE CONSISTENT WITH HISTORICAL MEASUREMENTS. 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 25636157 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN WEEKS AFTER A DEVICE EXCHANGE PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25355660 ↗
• MalfunctionMay 13, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 25158433 ↗
• MalfunctionApr 27, 2026Intermittent Capture; Electrical /Electronic Property Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS AND AN INABILITY TO CONFIRM CONSISTENT CAPTURE ON THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THERE WAS AN ATRIAL LEAD POSITION CHECK 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 25006134 ↗
• MalfunctionApr 24, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND CAUSING UNNECESSARY 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 24982317 ↗
• MalfunctionApr 17, 2026Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. A FAILED ATRIAL LEAD POSITION CHECK WAS ALSO NOTED. 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 24907710 ↗
• InjuryMar 19, 2026Signal Artifact/Noise; Intermittent Capture; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A FRACTURE, INTERMITTENT CAPTURE AND NOISE SENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE, RISING PACING IMPEDANCE AND HIGH THRESHOLDS. THE RA AND RV LEADS WERE EXPLANTED AND WERE REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AND WAS REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637297 ↗
• MalfunctionFeb 25, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA (AT) /ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 24444528 ↗
• MalfunctionFeb 25, 2026Electrical /Electronic Property Problem; 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 EVENTS IN PROGRESS. ADDITIONALLY, IT WAS NOTED THAT THERE WAS A RA LEAD POSITION CHECK FAILURE. 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 24443769 ↗
• MalfunctionFeb 16, 2026Over-Sensing; Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS FURTHER NOTED THAT THE RA LEAD EXHIBITED UNDERSENSING/OVERSENSING, INAPPROPRIATE PACING AND HIGH THRESHOLDS. THE RA LEAD REMAINS 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 24344712 ↗
• MalfunctionJan 30, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING AND ATRIAL EVENTS FALLING IN BLANKING PERIOD ON STORED EPISODES RESULTING IN MISCLASSIFICATION OF VENTRICULAR TACHYCARDIA (VT)-NON-SUSTAINED EPISODE AND UNNECESSARY ATRIAL 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 24221005 ↗
• MalfunctionJan 14, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED SPIKED IN IMPEDANCE. 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 24065346 ↗
• MalfunctionJan 13, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS, WITH ATRIAL PACING NOTED AT TIMES IMPACTING MODE SWITCH. IT WAS ALSO REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND THRESHOLD INCREASED SINCE BASELINE IMPLANT. THE RA LEAD AND RV LEAD REMAIN IN USE. IT WAS FURTHER REPORTED THAT SUBSEQUENTLY, THE PATIENT PASSED AWAY APPROXIMATELY TWO DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059061 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AND INFECTION AND EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED AND THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23680251 ↗
• InjuryOct 15, 2025High 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 COMPLICAT IONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298111 ↗
• InjurySep 2, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HIGH IMPEDANCE AND HIGH THRESHOLDS. 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 22932162 ↗
• InjuryAug 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD WAS CAPPED AND REPLACED USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768672 ↗
• MalfunctionJul 25, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR RISING IMPEDANCE. 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 22608996 ↗
• MalfunctionJun 10, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. 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 22177543 ↗
• MalfunctionJun 6, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS INTERMITTENT RIGHT ATRIAL (RA) LEAD 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 22155872 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT PRESENTED TO PREPARATION AND RECOVERY FOR DEVICE EXPLANT. THE PATIENT WAS INITIALLY ADMITTED FOR A FOOT ULCER WITH POSITIVE BLOOD CULTURES, THAT HAD MOVED TO THE PATIENT'S LEFT ELBOW. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND SHOWED BACTERIAL GROWTH ON THE VALVES AND LEADS. THE DEVICE AND LEAD WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Ulcer

  MAUDE report 22014509 ↗