Capsurefix DXAC/DSPRecalls & reported problems across all models

We found 2 models of Capsurefix DXAC/DSP by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 372 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2016 and Aug 26, 2026 — classified as 5 deaths, 155 injuries, 212 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (124 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Capsurefix DXAC/DSP problems

Capsurefix DXAC/DSP models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Capsurefix® DXAC/DSP 5568-45

  permanent pacemaker Electrode
  4 deaths192 reports
• Capsurefix® DXAC/DSP 5568-53

  Permanent defibrillator electrodes
  1 death180 reports

Recent Capsurefix DXAC/DSP adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 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 ↗
• 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 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 ↗
• 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 ↗

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