CAPSUREFIX® NOVUS 5076-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00681490730099), received between Aug 5, 2015 and Feb 18, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Signal Artifact/Noise; Intermittent Capture; Failure to Capture; Fracture; Over-Sensing; Pacing Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE ON CURRENT ELECTROGRAMS (EGM). THE RV LEAD AND RA LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Bradycardia; Chest Pain; Diaphoresis; Discomfort; Dizziness; Dyspnea; No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes; Pain; Palpitations; Presyncope; Syncope/Fainting

  MAUDE report 24375592 ↗
• InjuryDec 6, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO ATRIAL CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO RV CAPTURE AND NO SENSING. BOTH LEADS WERE CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864368 ↗
• MalfunctionFeb 2, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, AT DEVICE CLASSIFIED TERMINATION OF EVENTS, ARRHYTHMIA APPEARS TO CONTINUE DUE TO POSSIBLE ATRIAL UNDER SENSING. 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 18630667 ↗
• InjuryMay 30, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE AND HAD FRACTURED. THE RA 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 17018730 ↗
• InjuryMay 24, 2023High 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 COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990677 ↗
• MalfunctionFeb 3, 2023Signal Artifact/Noise; Decreased Sensitivity; Signal Artifact/Noise; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE MYOPOTENTIAL NOISE THAT WAS REPRODUCED WITH ISOMETRICS. THE RA LEAD ALSO EXHIBITED SMALL P-WAVES. THE RA LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291913 ↗
• InjuryJul 18, 2022Break; Intermittent Capture; Failure to Capture; Fracture; High impedance; Impedance Problem; Break; Intermittent Capture; Failure to Capture; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE AND NO CAPTURE WITH HIGH IMPEDANCE AND A SPIKE IN IMPEDANCE WHEN THE PATIENT ROLLS ONTO THEIR RIGHT SIDE. IT WAS FURTHER NOTED THE RA LEAD FRACTURED AND EXHIBITED A SUSPECTED SUBCLAVIAN CRUSH AS THE ISSUE WAS ONLY OBSERVED WHEN THE PATIENT ROLLS ON THEIR RIGHT SIDE. THE RA 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 15042074 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. IT WAS NOTED THAT THERE WAS BLOODY DRAINAGE FROM THE RIGHT SIDED INCISION SITE AND SUBSEQUENT DRAINAGE FROM THE LEFT SIDE POCKET ALSO. THE PATIENT STATED THE DRAINAGE TURNED BROWN IN COLOR. 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 14071194 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE RIGHT ATRIAL (RA) LEAD, THE RIGHT VENTRICULAR (RV) LEAD AND THE ADAPTER WERE REMOVED. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EPI-ANT RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13665676 ↗
• MalfunctionAug 6, 2021Degraded; Degraded

  THE RIGHT ATRIAL (RA) LEAD WAS REPLACED ELECTIVELY. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, 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 12291157 ↗
• InjuryApr 1, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDEFINED BIPOLAR IMPEDANCE QUALIFIED AS HIGH. THE RA LEAD WAS REPROGRAMMED TO UNIPOLAR AND REMAINS 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 9910260 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE RIGHT ATRIAL (RA) LEAD WAS NOTED TO BE TUNNELED FROM RIGHT. THE RA LEAD WAS ADJUSTED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9659137 ↗
• MalfunctionOct 30, 2019Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAK SPELLS. IT WAS ALSO REPORTED THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND UNDERSENSING ON STORED ELECTROGRAMS (EGM). THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Weakness

  MAUDE report 9254322 ↗
• MalfunctionSep 12, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. THE LEAD REMAINS 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 9007932 ↗
• MalfunctionAug 14, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT OVERSENSING DURING RECORDED ARRHYTHMIA EPISODES. THE RA LEAD REMAINS 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 8892753 ↗
• MalfunctionJun 20, 2018Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING WAS NOTED ON SOME STORED EPISODES. THE PATIENT UNDERWENT DEFIBRILLATION THRESHOLDS TESTING, WHICH WAS SUCCESSFUL WITHOUT COMPLICATIONS. THE LEAD REMAINS IN USE AND NO CHANGES WERE MADE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621118 ↗
• InjuryAug 5, 2015Failure to Capture; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. THE LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLDS AND NO CAPTURE. DURING THE EXTRACTION OF THE LEAD, THE PATIENT'S SUPERIOR VENA CAVA (SVC) WAS TORN; THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 4972591 ↗