CAPSUREFIXRecalls & reported problems across all models

We found 2 models of CAPSUREFIX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 444 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Sep 18, 2026 — classified as 3 deaths, 184 injuries, 257 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (181 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 problems

CAPSUREFIX models

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

• CAPSUREFIX® 5568-45

  Permanent defibrillator electrodes
  2 deaths235 reports
• CAPSUREFIX® 5568-53

  Permanent defibrillator electrodes
  1 death209 reports

Recent CAPSUREFIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited intermittent oversensing on atrial high rate episodes. 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 50814087 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. 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: Unspecified Infection

  MAUDE report 50756619 ↗
• 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 ↗
• MalfunctionJul 27, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037246 ↗
• MalfunctionJul 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOTED ON STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) 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 25724649 ↗
• 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 ↗
• MalfunctionApr 17, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS 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 24909193 ↗
• 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 ↗
• MalfunctionMar 18, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE, RESULTING IN TERMINATION OF THE AT/AF DETECTED EVENT IN PROGRESS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD RECENTLY EXHIBITED AN INCREASE IN PACING IMPEDANCE AND VARYING PACING IMPEDANCE. THE LV LEAD PACING IMPEDANCE WAS HIGH AND OUT-OF-RANGE. THE LV LEAD ALSO EXHIBITED A RECENT INCREASE IN THRESHOLDS, WITH A POSSIBLE LOSS OF CAPTURE. THE LV LEAD THRESHOLDS WERE HIGH. 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 24628400 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls