CapSureFix Novus MRI™ SureScan™ 5076-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 00763000014698), received between Dec 13, 2017 and Sep 9, 2026 — classified as 5 deaths, 159 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (104 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 329 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Failure to Capture; Pacing Problem; Under-Sensing

  It was reported that the Implantable Pulse Generator (IPG) exhibited beats in the blanking period on stored episode resulting in ina ppropriate atrial pacing with atrial loss of capture. It was also reported that the Right Atrial (RA) lead exhibited undersensing on stored episode resulting in inappropriate pacing with atrial loss of capture. The IPG 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 50689018 ↗
• 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 50476512 ↗
• InjuryAug 19, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited a warning for out of range high 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 50317371 ↗
• MalfunctionJul 2, 2026Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, AND UNDERSENSING RESULTING IN UNNECESSARY PACING. 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 25690994 ↗
• MalfunctionJun 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED 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 25421034 ↗
• MalfunctionMay 26, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. ADDITIONALLY, THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 25285349 ↗
• MalfunctionMay 19, 2026Over-Sensing

  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 25214203 ↗
• MalfunctionMay 13, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF SHORT SOMEWHAT CYCLICAL NOISE. 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 25164991 ↗
• MalfunctionMay 5, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND ALSO CAUSING UNNECESSARY ATRIAL PACING AT TIMES. 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 25079302 ↗
• MalfunctionApr 16, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS IN PROGRESS. 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 24904858 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 24783316 ↗
• InjuryMar 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED POST POCKET CLOSURE. THE 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 24727166 ↗
• MalfunctionMar 23, 2026Pacing Problem

  IT WAS REPORTED THAT ON STORED EPISODES THERE WERE ATRIAL EVENTS FALLING IN THE BLANKING PERIOD. THERE WERE ALSO OBSERVED DEVICE CLASSIFIED TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS, WITH INAPPROPRIATE ATRIAL PACING. THE RIGHT ATRIAL (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 24663071 ↗
• MalfunctionMar 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568529 ↗
• MalfunctionFeb 26, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER NOTED THAT THERE WAS A LOW P WAVE AMPLITUDE MEASUREMENT 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 24456264 ↗
• MalfunctionFeb 13, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING FALSE ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) DETECTIONS. SOME ATRIAL AND VENTRICULAR UNDERSENSING OBSERVED ON STORED EPISODE, HEALTH CARE PROFESSIONAL (HCP) STATED THAT PATIENT WAS IN AN OPERATIVE PROCEDURE AT THE TIME OF THIS STORED EPISODE. 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 24330759 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THEN REPLACED TWO WEEKS LATER DUE TO INFECTION AND REDNESS. THE SOURCE OF THE INFECTION WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 24152619 ↗
• MalfunctionDec 17, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE DETECTION. 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 23832347 ↗
• MalfunctionDec 10, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. 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 23767051 ↗
• InjuryOct 31, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE. 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 23434194 ↗
• InjuryOct 15, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS NOT EXPLANTED. THE RV LEAD WAS PUT INTO THE LEFT VENTRICULAR (LV) PORT AND PROGRAMMED OFF. THE RV LEAD REMAINS IN THE PATIENT.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289224 ↗
• MalfunctionSep 15, 2025Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT P WAVE UNDER-SENSING WHICH RESULTED IN A PACEMAKER DEFINED PREMATURE VENTRICULAR CONTRACTIONS (PVC) WITH A LONG PVARP AND THE DEVICE WAS NOT TRACKING WELL. PHRENIC STIMULATION WAS NOTED IN ALL VECTORS. SMALL P WAVES WERE NOTED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 23051461 ↗
• InjurySep 8, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE AND EXHIBITED LOSS OF CAPTURE. THE 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 22992988 ↗
• InjurySep 8, 2025Over-Sensing; Under-Sensing; Adverse Event Without Identified Device or Use Problem; Over-Sensing; Under-Sensing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND UNDERSENSING ON ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. BOTH THE RA AND THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22991783 ↗
• MalfunctionAug 27, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED ELECTROGRAMS (EGM). 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 22903756 ↗