CAPSUREFIX® 5568-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 00885074248448), received between Apr 6, 2017 and Sep 18, 2026 — classified as 2 deaths, 96 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (93 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 235 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 12, 2026Under-Sensing; Decreased Sensitivity

  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. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED LOW P WAVES. THE RA 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 24578443 ↗
• MalfunctionJan 30, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING 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 24222928 ↗
• MalfunctionJan 12, 2026High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) POTENTIALLY HAD ELECTROMAGNETIC INTERFERENCE/NOISE INTERFERENCE. THE RA LEAD ALSO EXHIBITED HIGH THRESHOLDS. THE IPG 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 24034580 ↗
• MalfunctionDec 22, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING ON STORED ELECTROGRAMS (EGM). 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 23862353 ↗
• MalfunctionDec 9, 2025Under-Sensing; 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 ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS 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 23753554 ↗
• MalfunctionDec 2, 2025Under-Sensing; Low impedance; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND LOW IMPEDANCES. 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 23690593 ↗
• MalfunctionNov 12, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A WARNING FOR HIGH THRESHOLD. THE LEAD APPEARED TO BE UNDERSENSING AT TIMES. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535279 ↗
• InjuryOct 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS A LOW PACING IMPEDANCE ALERT ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD TRIGGERING FALSE TERMINATION OF STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS AND HAD BEEN HOSPITALIZED. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369261 ↗
• MalfunctionOct 22, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT TRIGGERED DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) EVENTS 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 23358415 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT CULTURES WERE NEGATIVE FOR INFECTIOUS AGENTS AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS.

  Patient problems: Pocket Erosion

  MAUDE report 22912538 ↗
• MalfunctionJul 29, 2025Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing; High Capture Threshold; Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES AND INAPPROPRIATE PACING AT TIMES. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD POSITION CHECK FAILURE. ADDITIONALLY, THE RA LEAD EXHIBITED 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 22640887 ↗
• InjuryJul 25, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET WAS PAINFUL AND THE DEVICE WAS NOTED TO HAVE MIGRATED. IT WAS ALSO REPORTED THAT HIGH RIGHT ATRIAL (RA) LEAD THRESHOLDS WERE NOTED. THE DEVICE POCKET WAS REVISED AND THE CRT-D REMAINS IN USE. THE RA LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615233 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. 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: Unspecified Infection

  MAUDE report 22563959 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRAUMA AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SITE, A WOUND DEVELOPED AND THE DEVICE ERODED. THE DEVICE WAS EXPLANTED 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: Pocket Erosion

  MAUDE report 22347246 ↗
• MalfunctionJun 3, 2025Under-Sensing; 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) EVENT(S) 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 22129781 ↗
• MalfunctionMay 23, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, HIGH UNDEFINED IMPEDANCE AND NO CAPTURE. 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 22077752 ↗
• InjuryMay 7, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED 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 21975654 ↗
• InjuryApr 22, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITING HIGH THRESHOLD AND DIMINISHED SENSING. THE LEADS WERE ATTEMPTED TO BE REVISED. DURING THE REVISION PROCEDURE, OCCLUSION WAS NOTED. THEREFORE, THE LEADS WERE NOT REVISED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21880845 ↗
• MalfunctionApr 4, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD NOTED ON STORED ELECTROGRAMS (EGM), RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND 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 21772167 ↗