CAPSUREFIX® NOVUS 5076-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00681490729963), received between Apr 17, 2017 and Apr 1, 2026 — classified as 27 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (11 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND FALSE TERMINATION OF EPISODES SAVED. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND FLUCTUATING THRESHOLDS. THE RA AND RV LEADS WERE REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations

  MAUDE report 24754971 ↗
• MalfunctionJan 2, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING WITH POSSIBLE NOISE RESULTING IN MISCLASSIFICATION OF EPISODE TYPES. THE ICD 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 23951700 ↗
• InjuryDec 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED FEVER, SHAKING AND CHILLS. IT WAS ALSO FURTHER REPORTED THAT VEGETATION WAS NOTED ON THE RV LEAD.

  Patient problems: Chills; Fever; No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Shaking/Tremors; Unspecified Infection

  MAUDE report 23919863 ↗
• MalfunctionJan 10, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS FURTHER REPORTED THAT ELECTROGRAMS (EGM) SHOWED TWO ATRIAL PACE MARKERS IN NEAR IMMEDIATE SUCCESSION. SUBSEQUENT ATRIAL PACE MARKERS DID NOT APPEAR TO BE RESCHEDULED BY A SECOND ATRIAL PACE. A POSSIBLE TELEMETRY ERROR WAS SUSPECTED. THE RA LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 21127229 ↗
• InjuryOct 14, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE IN VENTRICULAR FIBRILLATION (VF) AND CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED BY THE EMERGENCY MEDICAL SERVICES. THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND WAS HYPERTENSIVE. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. THE PATIENT WAS INTUBATED AND MEDICATED. UNDERSENSING AND THE INABILITY TO APPROPRIATELY MODE SWITCH LEADING TO INAPPROPRIATELY PACING THAT DEGRADED INTO VT / VENTRICULAR FIBRILLATION (VF). IT WAS SUSPECTED THAT THE SCAR MEDIATED VT ARREST. THE PATIENT HAD INTERMITTENT FEVER POST ADMISSION AND LEUCOCYTOSIS. A SECOND-DEGREE BURN RESULTING FROM RESUSCITATION CAUSED A STERNAL WOUND RESULTING IN AN EXTERNAL HEMATOMA. THE IPG SYSTEM REMAINS IN THE PATIENT AND DURING THE REPLACEMENT PROCEDURE OCCLUSION / ADHESION WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD. THE IPG SYSTEM WAS REPLACED ON THE RIGHT SIDE OF THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Adhesion(s); Cardiac Arrest; Fever; Hematoma; Obstruction/Occlusion; Tachycardia; Unspecified Infection; Ventricular Fibrillation

  MAUDE report 20438332 ↗
• InjuryMar 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD INTERACTED WITH THE RIGHT VENTRICULAR (RV) LEAD WHICH CAUSED RV LEAD ISSUES. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT TOTALLY HAPPY WITH HOW THEY WERE FEELING WITH THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) AND DUE TO THEIR SYMPTOMS, THE LEADLESS IPG WAS INACTIVATED AND REPLACED WITH A TRANSVENOUS SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003487 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE CRTD SYSTEM WAS REPLACED. STAPHYLOCOCCUS EPIDERMIS WAS ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 18861789 ↗
• InjuryNov 2, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE. A PACING PROBLEM AND LOSS OF CAPTURE OCCURRED WITH PROBABLE CONNECTOR, HEADER ISSUE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE RIGHT VENTRICULAR (RV) LEAD SHOWED PERIODS OF PACER SPIKES WITH NO CAPTURE AND INTERMITTENT CAPTURE. A LEAD DISLODGEMENT WAS CONFIRMED. MANUAL RV LEAD THRESHOLD TESTING WAS VARIABLE. THE RIGHT ATRIAL (RA) LEAD SHOWED PERIODS OF PACER SPIKES WITH NO CAPTURE. THE CRT-D WAS EXPLANTED AND REPLACED. THE RV LEAD WAS RE-POSITIONED AND REMAINS IN USE. THE RA LEAD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 18059946 ↗
• MalfunctionJun 19, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS SUSPECTED ATRIAL UNDERSENSING DURING 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 17151454 ↗
• InjuryJun 16, 2023Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ARRHYTHMIA AND ASYSTOLE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE PATIENT HAD GROWN SINCE IMPLANT LEADING TO REDUCED SLACK AND WAS ABLE TO CAPTURE IN UNIPOLAR ONLY. THE RA LEAD WAS ELECTIVELY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Asystole

  MAUDE report 17142729 ↗
• InjuryJun 9, 2023Signal Artifact/Noise; Failure to Capture; Collapse; Over-Sensing; Device-Device Incompatibility; Signal Artifact/Noise; Failure to Capture; Collapse; Over-Sensing; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUES TO HAVE DIZZY SPELLS AND A PATIENT ACTIVATOR WAS ORDERED FOR THE IPG TO MARK SYMPTOMS.

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 17096599 ↗
• MalfunctionJan 17, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA AND RV 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 16183784 ↗
• InjuryNov 16, 2022Failure to Capture; High Capture Threshold; Unstable Capture Threshold; Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH AND UNSTABLE THRESHOLDS AND LOSS OF CAPTURE. THE RA LEAD WAS PROGRAMMED OFF AND THEN SUBSEQUENTLY 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 15804020 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST IMPLANT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15281014 ↗
• InjuryAug 22, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING HIGH IMPEDANCE. THE RA LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264985 ↗
• InjuryJun 22, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, HOLTER MONITOR INDICATED SHORT PERIODS OF VENTRICULAR NON CAPTURE IN THE EARLY MORNING HOURS. THE RIGHT VENTRICULAR SENSITIVITY WAS RE-PROGRAMMED AND, 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 14776126 ↗
• InjuryNov 29, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH SYNCOPE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED SUSPECTED LOSS OF CAPTURE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 12880898 ↗
• MalfunctionJun 11, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING 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 11982175 ↗
• MalfunctionFeb 11, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE SEEMS TO BE INTERMITTENTLY UNDER-SENSING 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 11312650 ↗
• InjuryNov 9, 2020Failure to Capture; High impedance; Device Sensing Problem; Failure to Capture; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-CAPTURE, HIGH IMPEDANCE AND POOR SENSING. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10808864 ↗
• MalfunctionOct 23, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE. CAPTURE MANAGEMENT WILL NOT RUN DUE TO ATRIOVENTRICULAR BLOCK AND 99% RA PACING WHICH IS A NORMAL LIMITATION OF THE DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10725188 ↗
• MalfunctionJul 7, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239168 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REPROGRAMMING OF RIGHT ATRIAL (RA) LEAD FOR AN UNKNOWN ISSUE, THE PATIENT EXPERIENCED STIMULATION SO MUCH THAT THE PATIENT JUMPED IN THE CHAIR AND EXPERIENCED SAME STIMULATION TWO NIGHTS LATER IN THEIR HOME. THE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10070012 ↗
• InjuryApr 27, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THERE WAS A POSSIBLE FRACTURE ON THE RIGHT ATRIAL (RA) LEAD AND IT ALSO EXHIBITED HIGH AND UNDEFINED IMPEDANCE READINGS, IT WAS NOTED ON AN X-RAY THAT AS THE PATIENT GREW THE LEAD APPEARED TO STRETCH TO THE POINT OF FRACTURE. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000159 ↗
• InjuryMar 3, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND PALPITATIONS. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVER-SENSING OF FAR FIELD R-WAVES (FFRW). THE RA LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations; Syncope

  MAUDE report 9778833 ↗