CAPSUREFIX® NOVUS 407658 (UDI 00885074200699)Recalls & reported problems

Summary

The FDA's MAUDE database contains 813 adverse event reports that list this exact device (DI 00885074200699), received between Dec 9, 2016 and Sep 28, 2026 — classified as 11 deaths, 461 injuries, 341 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (206 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 813 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Pacing Problem; 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 AT/AF detected event(s) in progress and causing inappropriate atrial pacing. It was further reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The RA lead and RV 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 50911805 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing; Decreased Sensitivity

  It was reported that the Right Ventricular (RV) lead exhibited under sensing  resulting in inappropriate RV pacing during true arrhythmia. It was further reported that the RV lead 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 50911193 ↗
• MalfunctionSep 25, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited 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 50895739 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that shortly after the Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a large hematoma on the left side for which incision and drainage was performed on the left side. It was suspected that subsequently the patient developed infection with weakness, bacteremia, erosion and organism identified as Methicillin sensitive staphylococcus aureus (MSSA). The CRT-D system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Erosion; Muscle Weakness/Atrophy

  MAUDE report 50869834 ↗
• MalfunctionSep 18, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Discomfort

  MAUDE report 50827974 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise

  It was reported that the Right Atrial (RA) lead exhibited high thresholds, a decline in P waves, possible non capture with P-waves p resent and unnecessary mode switching resulting in ventricular pacing not tracking P-waves, Far Field R-Wave (FFRW) oversensing triggering Atrial Tachycardia/Atrial Fibrillation (AT/AF) episode misclassification and noise. The Right Ventricular (RV) lead was also noted to exhibit noise. The RA lead and RV 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 50774183 ↗
• MalfunctionSep 8, 2026Decreased Sensitivity

  It was reported that the  Right Ventricular (RV) lead exhibited a decrease in R-Wave measurement. 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 50667214 ↗
• MalfunctionSep 7, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647994 ↗
• InjuryAug 20, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient had a cardiac procedure in which the physician had dislodged the Right Ventricular (RV) lead, resulting in occasional loss of capture due to underlying complete heart block. The patient experienced asystole. The RV lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Asystole

  MAUDE report 50345879 ↗
• MalfunctionAug 19, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321678 ↗
• MalfunctionAug 18, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295797 ↗
• InjuryAug 11, 2026Adverse 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 50214325 ↗
• MalfunctionJul 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNDER SENSING. 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 25676124 ↗
• MalfunctionJun 23, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD ALERT. 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 25593806 ↗
• MalfunctionJun 16, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ARRHYTHMIA EPISODES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520030 ↗
• MalfunctionJun 11, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD RETURNED FOR ANALYSIS AND TESTED OUT-OF-SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468179 ↗
• MalfunctionJun 10, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25454973 ↗
• MalfunctionJun 9, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS. 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 25443104 ↗
• MalfunctionJun 4, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SIGNIFICANT INCREASE IN THRESHOLDS. THE LEAD REMAINS IN USE. NO PAT IENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392480 ↗
• MalfunctionMay 29, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25331868 ↗
• InjuryMay 28, 2026Intermittent Capture; Low impedance; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE, HIGH AND RISING THRESHOLDS, AND INTERMITTENT CAPTURE. THE RV LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 25315780 ↗
• 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 25215509 ↗
• MalfunctionMay 19, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 25214240 ↗
• MalfunctionMay 12, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING, CAUSING INAPPROPRIATE PACING AT TIMES. 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 25148301 ↗
• MalfunctionMay 12, 2026High Capture Threshold

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25146441 ↗