Capsurefix® DXAC/DSP 5568-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 00613994776853), received between Apr 7, 2016 and Aug 20, 2026 — classified as 1 death, 72 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (60 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 180 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) 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 50350048 ↗
• InjuryJun 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 COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573608 ↗
• MalfunctionMay 19, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND BLANKING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS WHICH RESULTED IN UNNECESSARY PACING, MISCLASSIFICATION OF NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES, AND THE TERMINATION OF THE AT/AF DETECTED EVENTS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND/ OR BLANKING WHICH RESULTED IN OVER PACED BEATS. LOW P WAVES WERE ALSO OBSERVED. 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 25215466 ↗
• InjuryFeb 16, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN BOTH BIPOLAR AND UNIPOLAR IMPEDANCE AND AN OUR OF RANGE IMPEDANCE WARNING. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A NUMBER OF SHORT CIRCUIT PACE COUNTS AND MINERALIZATION OF THE TIP ELECTRODE. THE LEAD REMAINS IN USE. 2026-02-16: IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A FALL AND A CHEST X-RAY WAS PERFORMED AT THAT TIME WHICH DID NOT REVEAL ANY LEAD OR DEVICE ABNORMALITIES. IT WAS ALSO NOTED NO MEASURABLE R-WAVES WERE OBSERVED AND HIGH ATRIAL SENSING INTEGRITY COUNTER (SIC) WAS NOTED. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 24342990 ↗
• MalfunctionFeb 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. 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 24256270 ↗
• MalfunctionJan 7, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING INHIBITION BUT A CAUSE COULD NOT BE DETERMINED. PROVOCATIVE TESTS WERE PERFORMED, HOWEVER ALL THAT WAS NOTED DURING THE TESTING WAS A LITTLE NOISE ON THE RIGHT ATRIAL (RA) LEAD. AN X-RAY SHOWED THAT THE RV LEAD WAS VERY CLOSE TO A PREVIOUSLY CAPPED COMPETITOR LEAD WHICH MAY INDICATE THAT LEAD TO LEAD INTERACTION COULD BE THE CAUSE OF THE PACING ISSUE. THE RA LEAD REMAINS IN USE. THE RV 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 23992265 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HE HAD AN INFECTED LEFT BIG TOE, WHICH LEAD TO THEIR BONE GETTING INFECTED AND THEN IT BECOMING SYSTEMIC. THE PATIENT ALSO EXPERIENCED STAPHYLOCOCCUS AUREUS, PAIN, FEVER AND SWELLING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23864215 ↗
• MalfunctionNov 6, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. IT WAS ALSO NOTED THAT THE RA LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. 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 23486763 ↗
• MalfunctionOct 22, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE THRESHOLDS WERE CHRONICALLY ELEVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357752 ↗
• MalfunctionSep 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 23073951 ↗
• MalfunctionAug 22, 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 (AT)/ ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES AND ALSO 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 22871078 ↗
• MalfunctionAug 21, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING AND HIGH THRESHOLDS. 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 22859433 ↗
• InjuryJul 28, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE RA LEAD WAS CAPPED AND REPLACED. THE IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628486 ↗
• InjuryJul 2, 2025Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING IMPEDANCES AND INCREASING THRESHOLDS. THE RA LEAD WAS CAPPED AND RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380524 ↗
• InjuryJun 10, 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) SYSTEM WAS EXPLANTED DUE DEVICE POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 22177075 ↗
• InjuryJun 6, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD ELEVATED IMPEDANCE AND THE RIGHT VENTRICULAR (RV) LEAD HAD AN INSULATION BREACH. THE IPG SYSTEM 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 22157792 ↗
• MalfunctionJun 3, 2025Signal Artifact/Noise; Decreased Sensitivity; Signal Artifact/Noise; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING AND SMALL P WAVES. 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 22130227 ↗
• InjuryApr 30, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. 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 21933465 ↗
• MalfunctionApr 24, 2025Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing; Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. AN INTERROGATION REPORT INDICATED THAT THE RIGHT ATRIAL (RA) LEAD POSITION CHECK FAILED AND THE RA LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION, INAPPROPRIATE PACING AND MISCLASSIFICATION OF VENTRICULAR TACHYCARDIA NON-SUSTAINED AND SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES. IN ADDITION, THE INAPPROPRIATE RA PACING LEAD TO A BLANKED VENTRICULAR EVENT THAT CAUSED A FUNCTIONAL LOSS OF RIGHT VENTRICULAR (RV) LEAD CAPTURE OF VENTRICULAR PACED EVENT. THE RA AND THE RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 21897677 ↗
• MalfunctionMar 26, 2025Pacing Problem; Under-Sensing; Decreased Sensitivity; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDER SENSING, TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES. THE ATRIAL UNDER SENSING APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING AND AFFECTED MODE SWITCH AT TIMES. A LOW P WAVE AMPLITUDE WAS NOTED. 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 21696569 ↗
• 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 21374442 ↗
• InjuryFeb 6, 2025High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322173 ↗
• InjuryFeb 5, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED FIVE PARTIAL AND ONE FULL RESET. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, OVERSENSING AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE IPG AND RA LEAD WERE REPROGRAMMED AND 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 21313613 ↗
• InjuryFeb 5, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH ATRIAL THRESHOLD AND IMPEDANCE. THE LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313395 ↗
• MalfunctionJan 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND A DROP IN DEFIBRILLATION IMPEDANCE. IT WAS NOTED THAT THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RV LEAD 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 21219805 ↗