CapSureFix Novus MRI™ SureScan™ 5076-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00763000014704), received between Dec 7, 2017 and Aug 27, 2026 — classified as 3 deaths, 51 injuries, 45 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pocket erosion. The Implantable Pulse Generator (IPG), Right Ventricular (RV) lead, and Right Atrial (RA) lead were explanted and another RV lead was capped. The system was replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Pocket Erosion

  MAUDE report 50476510 ↗
• MalfunctionMay 19, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. UPON DEVICE ASSESSMENT IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING, TRIGGERING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) DETECTIONS. REPORTS OF HEART RATES IN THE TWENTIES WERE REPORTED, WITH POSSIBLE NON-CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25214242 ↗
• InjuryMar 25, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT FELT THEIR HEART "SKIPPING". IT WAS ALSO REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. MIRROR IMAGE OVERSENSING WAS ALSO NOTED TO BE OBSERVED. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 24687120 ↗
• InjuryFeb 4, 2026Break; Intermittent Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV PACING IMPEDANCE AND INTERMITTENT RV CAPTURE. AN INSULATION ISSUE WAS NOTED. 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 24256705 ↗
• MalfunctionJan 12, 2026Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND A POLARITY SWITCH. 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 24036516 ↗
• MalfunctionJun 10, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON SOME STORED ELECTROGRAMS (EGM) RESULTING IN INAPPROPRIATE PACING. 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 22174225 ↗
• MalfunctionMay 6, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES AND MODE SWITCH. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING AND SHORT V-V INTERVALS. BOTH THE RA 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 21967294 ↗
• MalfunctionMar 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS. 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 21583148 ↗
• InjuryFeb 12, 2025Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363552 ↗
• MalfunctionNov 27, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDER SENSING AS NOTED ON STORED ELECTROGRAMS (EGM), WHICH RESULTED IN INAPPROPRIATE VENTRICULAR PACING. 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 20798572 ↗
• MalfunctionNov 5, 2024Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT DURING USE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND FLUCTUATING THRESHOLDS.  THE RV LEAD REMAINS IN U SE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610942 ↗
• MalfunctionOct 23, 2024Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DIMINISHED 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 20513329 ↗
• InjuryJul 12, 2024Electrical /Electronic Property Problem; High impedance; Over-Sensing; Pacing Problem; Capturing Problem; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Pacing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND PAUSE WAS NOTED WHILE TRANSPORTING TO HOSPITAL. RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNDEFINED LEAD IMPEDANCE WARNING IN UNIPOLAR AND BIPOLAR CONFIGURATION AND POLARITY SWITCH. RECENT INCREASE IN THRESHOLDS WERE NOTED ON THE RV LEAD. THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE HIGH UNIPOLAR IMPEDANCE. OVER-SENSING WAS NOTED ON THE RV LEAD DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. THE LEADS WERE CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 19728185 ↗
• InjuryJul 5, 2024Adverse 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 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 19678987 ↗
• InjuryMay 8, 2024Fracture; High impedance; Impedance Problem; High Capture Threshold; Fracture; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH IMPEDANCE AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RV LEAD WAS FRACTURED. THE RV LEAD WAS REPROGRAMMED AND THEN 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 19266573 ↗
• MalfunctionApr 9, 2024Low impedance; Low impedance

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ATRIAL FLUTTER ABLATION ON THE SAME DAY THE LOW IMPEDANCE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072232 ↗
• MalfunctionFeb 26, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE UNDERSENSING, WITH ARRHYTHMIAS APPEARING TO CONTINUE POST-DEVICE CLASSIFIED TERMINATION OF EVENTS. INTERMITTENT UNDERSENSING WAS ALSO NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. 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 18779540 ↗
• InjuryJan 3, 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 AN INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS SUBSEQUENTLY PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18439723 ↗
• MalfunctionDec 28, 2023Electrical /Electronic Property Problem; Over-Sensing; Impedance Problem; Electrical /Electronic Property Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) IMPEDANCE VALUES AND BOTH UNDERWENT A POLARITY SWITCH DURING AN ABLATION PROCEDURE. IT WAS ALSO NOTED THAT THE RV LEAD ALSO EXHIBITED OVERSENSING OF THE SENSING INTEGRITY COUNTER (SIC). 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 18409503 ↗
• InjuryOct 12, 2023Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HIGH THRESHOLDS AND RISING IMPEDANCE. 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 17918207 ↗
• InjurySep 5, 2023Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND A HIGH NUMBER OF SHORT VENTRICLE TO VENTRICLE INTERVALS. THE LEAD WAS REPROGRAMMED 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 17681816 ↗
• MalfunctionMay 31, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON RECORDED VENTRICULAR TACHYCARDIA (VT) EPISODES. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING NOTED TO CAUSE FALSE/EARLY TERMINATION OF MOST RECENT RECORDED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 17029231 ↗
• InjuryApr 24, 2023Signal Artifact/Noise; Intermittent Capture; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Intermittent Capture; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FRACTURE, HIGH IMPEDANCE, INTERMITTENT CAPTURE AND OVERSENSING NOISE ON ELECTROGRAMS (EGM). THE RV LEAD WAS CAPPED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795704 ↗
• InjuryApr 4, 2023Electrical /Electronic Property Problem; High impedance; Over-Sensing; High Capture Threshold; Electrical /Electronic Property Problem; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED LEAD IMPEDANCE WARNING AND POLARITY SWITCH, HIGH V-V INTERVAL SENSING INTEGRITY COUNTER (SIC) COUNT AND 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 16673529 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. BACTEREMIA WAS NOTED. 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: Bacteremia

  MAUDE report 16371591 ↗