CAPSUREFIX® NOVUS 407652 (UDI 00643169550810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 224 adverse event reports that list this exact device (DI 00643169550810), received between Dec 9, 2016 and Sep 17, 2026 — classified as 1 death, 90 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (89 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 224 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced a pocket infection with redness and bacter emia. The device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Erythema; Medical device site infection

  MAUDE report 50804866 ↗
• InjuryAug 17, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in misclassification of episode detection. It was noted that the patient received possibly inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy for Supra Ventricular Tachycardia (SVT) that was detected as Ventricular Tachycardia (VT). The RA lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50280811 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was removed due to a bacteremia infection the month following a generator replacement procedure. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50150805 ↗
• MalfunctionJul 2, 2026Impedance Problem

  IT WAS REPORTED THAT THE PACING LEAD EXHIBITED OUT OF RANGE (OOR) UNDEFINED IMPEDANCE. 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 25691668 ↗
• MalfunctionJul 1, 2026Pacing Problem; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE LOW IMPEDANCE AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ST ORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS, LACK OF DETECTION OF AT/AF, AND INAPPROPRIATE PACING. IT WAS ALSO NOTED THAT THERE WERE LOW AMPLITUDE P WAVES. BOTH LEADS REMAIN 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 25678359 ↗
• MalfunctionJun 24, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE SHOCKS AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL T ACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA. IT WAS FURTHER REPORTED THAT THERE WAS UNDERSENSING ON THE ATRIAL LEAD DURING STORED AT/AF EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND CAUSING INAPPROPRIATE ATRIAL PACING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ATRIAL LEAD REMAIN 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 25612706 ↗
• MalfunctionJun 17, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE. 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 25529283 ↗
• MalfunctionJun 2, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING THE RV 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 25358383 ↗
• MalfunctionApr 22, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDEFINED HIGH IMPEDANCE, OVERSENSING, AND NOISE TRIGGERING EPISODE MISCLASSIFICATION. 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 24951104 ↗
• MalfunctionMar 25, 2026Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING AND HIGH THRESHOLDS. THE RV 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 24685745 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE, REGURGITATION, CARDIAC PERFORATION AND CHEST PAIN. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DISLODGEMENT AND POSITIONING/PLACEMENT ISSUE. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Chest Pain; Syncope/Fainting; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24597506 ↗
• MalfunctionMar 13, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHARP PULSATING PAINS AND SHOCKS FROM THEIR IMPLANTABLE PULSE GENERATOR (IPG). IT WAS FURTHER REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED IMPEDANCE. THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24589259 ↗
• MalfunctionMar 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING WHICH WAS MARKED AS "AB", CAUSING INAP PROPRIATE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE DETECTION. 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 24530448 ↗
• MalfunctionFeb 19, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON THE VENTRICULAR LEAD RESULTING IN MISCLASSIFICATION OF EPISODE TYPE AND NOISE. THE RV 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 24386863 ↗
• MalfunctionJan 29, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING FALSE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. 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 24207987 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA. THE ORGANISM OF THE INFECTION WAS IDENTIFIED TO BE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 24128544 ↗
• MalfunctionJan 15, 2026Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE/NOISE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND A HIGH NUMBER OF SHORT V-V INTERVALS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. THE IPG, 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 24078091 ↗
• MalfunctionJan 12, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN MISCLASSIFICATION OF ARRHYTHMIA AND TERMINATION OF AT/AF DETECTED EVENT IN PROGRESS. THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED LEAD INTEGRITY ALERT (LIA)S FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE LEADS 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 24040789 ↗
• MalfunctionDec 8, 2025Over-Sensing; Pacing Problem; Under-Sensing; Decreased Sensitivity; Over-Sensing; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES, UNDERSENSING DURING AT/AF EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND LOW 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 23741516 ↗
• MalfunctionNov 12, 2025Pacing Problem; Under-Sensing; Decreased Sensitivity; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING FALSE TERMINATION OF EPISODE IN PROGRESS AS WELL AS INAPPROPRIATE ATRIAL PACING. THE LEAD ALSO EXHIBITED DIMINISHED SENSING. 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 23533143 ↗
• InjurySep 15, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POST BI-VENTRICULAR (BI-V) T-WAVE OVERSENSING (TWOS). THE RV LEAD WAS REPROGRAMMED. IT WAS ALSO REPORTED THAT RIGHT ATRIAL (RA) LEAD UNDERSENSING WAS NOTED ON CURRENT ELECTROGRAMS (EGM). 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 23059542 ↗
• InjuryAug 21, 2025Failure to Capture; Collapse; Fracture; Low impedance; Failure to Capture; Collapse; Fracture; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FRACTURE, LOW IMPEDANCE AND NO CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FRACTURE, LOW IMPEDANCE AND RISING THRESHOLD. IT WAS NOTED THAT THERE WAS APPARENT SUBCLAVIAN CRUSH. BOTH THE LEADS WERE EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862513 ↗
• MalfunctionAug 14, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A MISCLASSIFICATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS OCCURRED DUE TO FAR FIELD R-WAVE (FFRW) OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. 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 22806523 ↗
• MalfunctionAug 1, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL PACING AND TRIGGERING DEVIC E-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 22689405 ↗
• MalfunctionJun 17, 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 TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES RESULTING IN INAPPROPRIATE 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 22217483 ↗