CAPSUREFIX® NOVUS 5076110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902309656), received between Dec 19, 2019 and Oct 16, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Over-Sensing” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INSULATION BREACH. THE RV LEAD WAS REVISED AND WAS ATTEMPTED TO BE FIXED USING SEVERAL LEAD ANCHORING SLEEVES. THE RV LEAD HAS SINCE EXHIBITED OVERSENSING. FAR FIELD R-WAVE (FFRW) OVERSENSING WAS OBSERVED WHILE THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAS A PIN PLUG IN THE ATRIAL PORT. THE RV LEAD AND CRT-P 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 23308360 ↗
• MalfunctionJun 12, 2023Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) AND VENTRICULAR OVERSENSING WERE OBSERVED ON ELECTROGRAMS, WHICH HAD OCCURRED WHILE THE PATIENT WAS WORKING OUT. IN ADDITION, HIGH THRESHOLDS WERE SEEN ON THE RIGHT VENTRICULAR (RV) LEAD, AND ONE MODE SWITCH HAD OCCURRED. LATER THE RV LEAD HAD TWOS POST VENTRICULAR SENSE (VS) OR UNDERSENSING. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD HAD UNDERSENSING AND FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 17112276 ↗
• InjuryDec 19, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LONGEVITY WAS SHORTER THAN EXPECTED AND THE BATTERY VOLTAGE WAS RAPIDLY DEPLETING. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD EXHIBITED HIGH THRESHOLDS FOR QUITE A WHILE AND THE ATRIAL OUTPUTS WERE REPROGRAMMED. THE ICD AND ATRIAL LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9496722 ↗