CAPSUREFIX® NOVUS 407658 (UDI 00643169550827)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00643169550827), received between Dec 9, 2016 and Jul 10, 2026 — classified as 54 injuries, 32 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (26 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE HIGH 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 25779971 ↗
• MalfunctionJun 24, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH OUT OF RANGE (OOR) IMPEDANCE AND WAS FRACTURED. 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 25606716 ↗
• InjuryApr 3, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING IMPEDANCES AND RISING THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777218 ↗
• InjuryMar 5, 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 24517351 ↗
• InjuryMar 2, 2026High impedance; Impedance Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A GRADUAL INCREASE IN IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: Syncope/Fainting

  MAUDE report 24482364 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HE HAD AN INFECTED LEFT BIG TOE, WHICH LEAD TO THEIR BONE GETTING INFECTED AND THEN IT BECOMING SYSTEMIC. THE PATIENT ALSO EXPERIENCED STAPHYLOCOCCUS AUREUS, PAIN, FEVER AND SWELLING. 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: Bacterial Infection; Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23864186 ↗
• MalfunctionSep 18, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS ALONG WITH INCREASING SHORT V-V INTERVAL COUNTS ON SENSING INTEGRITY COUNTER (SIC) COUNTER. 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 23081627 ↗
• InjuryAug 21, 2025Collapse; Fracture; Low impedance; Capturing Problem; Collapse; Fracture; Low impedance; Capturing Problem

  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 22861666 ↗
• MalfunctionJun 24, 2025Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS SIGNIFICANTLY INCREASED AND RISING CAPTURE THRESHOLDS OBSERVED ON LEAD TREND REPORT FOR THE RIGHT VEN TRICULAR (RV) LEAD. IN-PERSON TESTING OF THE LEAD RESULTED IN HIGHER CAPTURE THRESHOLDS BUT THEY ARE ABLE TO MAINTAIN REASONABLE PROGRAMMED OUTPUT WITH AN ADEQUATE SAFETY MARGIN. 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 22317718 ↗
• MalfunctionJun 20, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OCCASIONAL UNDERSENSING DURING VENTRICULAR TACHYCARDIA (VT) EPISODES ON STORED ELECTROGRAMS (EGM). THE LEAD REMAINS 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 22296043 ↗
• MalfunctionApr 17, 2025Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FRACTURE IN BIPOLAR CONFIGURATION RESULTING IN HIGH UNDEFINED OUT OF RANGE BIPOLAR IMPEDANCE AND NO CAPTURE. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO RECEIVE MAGNETIC RESONANCE IMAGING (MRI) DUE TO THIS MALFUNCTION. 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 21857739 ↗
• MalfunctionFeb 6, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 21322264 ↗
• MalfunctionApr 4, 2024Pacing Problem; Impedance Problem; Pacing Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NORMAL DEVICE AND LEAD FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040782 ↗
• InjuryFeb 27, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV 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 18789335 ↗
• MalfunctionJan 24, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING 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 18569635 ↗
• InjuryOct 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO POCKET EROSION.  A NEW CRT-D SYSTEM WAS IMPLANTED THREE DAYS LATER.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17982038 ↗
• InjuryOct 4, 2023Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem; High Capture Threshold; Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIZZINESS AND SYNCOPE. AN INTERROGATION REPORT INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) IMPEDANCE AND RISING IMPEDANCE TRENDS. IN ADDITION, HIGH THRESHOLDS WERE EXHIBITED. THE RV LEAD POLARITY SWITCH WAS TRIGGERED. A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 17870470 ↗
• MalfunctionAug 18, 2023High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN SIGNIFICANT INCREASE IN RV CAPTURE THRESHOLD THEN A DECREASE. 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 17573003 ↗
• InjuryJul 21, 2023High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED OVERSENSING AND HAD DISLODGED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND HIGH UNDEFINED IMPEDANCE. THE RA LEAD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS REVISED AND 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 17369810 ↗
• MalfunctionMar 14, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT FELT A THUNDERBOLT CHEST PAIN AND EXPERIENCED POSSIBLE ATRIAL FIBRILLATION (AF). THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED HIGH THRESHOLDS. THE RV LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Chest Pain

  MAUDE report 16536679 ↗
• InjuryJan 23, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT-OF-RANGE HIGH BIPOLAR IMPEDANCE. IN ADDITION, IT WAS NOTED THAT THE LEAD ALSO DISPLAYED HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223795 ↗
• InjuryDec 28, 2022Over-Sensing; Decreased Sensitivity; Over-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THERE WAS A LARGE INCREASE IN THE SENSING INTEGRITY COUNTER (SIC). THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED DUE TO SMALL R WAVES. 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 16060056 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT SUBCLAVIAN VEIN, THROUGH WHICH THE RIGHT VENTRICULAR (RV) LEAD HAD BEEN DELIVERED, WAS KNOWN TO BE OCCLUDED. THE LEAD WAS INACTIVATED WHEN THE PATIENT WAS UPGRADED AND REQUIRED ADDITIONAL LEADS, AND REMAINS IN PLACE. THE NEW LEADS WERE IMPLANTED FROM THE PATIENT'S OPPOSITE SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15318951 ↗
• MalfunctionJul 11, 2022Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND R WAVES WERE NOTED TO BE LOW. 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 14974654 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. EPICARDIAL LEADS WERE PLACED AND A NEW IPG IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14929292 ↗