CapSureFix Novus MRI™ SureScan™ 407652 (UDI 00763000014643)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00763000014643), received between Dec 7, 2017 and Aug 13, 2026 — classified as 2 deaths, 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (10 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteraemia. The Implantable Pulse Generator (IPG) system was removed. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50232429 ↗
• MalfunctionJun 25, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE PATIENT EXPERIENCED SYNCOPE AND WAS STATED TO BE IN-PATIENT. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 25630518 ↗
• MalfunctionJun 22, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING ALONG WITH POSSIBLE IN TERMITTENT LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN UNNECESSARY PACING AT TIME. BOTH, THE RV AND 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 25573986 ↗
• DeathNov 6, 2024Under-Sensing; Under-Sensing

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622674 ↗
• MalfunctionOct 9, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN ATRIAL LEAD POSITION CHECK FAILURE. 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 20406114 ↗
• MalfunctionSep 2, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM), RESULTING IN INAPPROPRIATE MODE SWITCH, ATRIAL EVENTS APPEAR TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TAC HYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENT(S) AND DOES NOT APPEAR TO IMPACT THE DEVICE FUNCTION OR PERFORMANCE. 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 20117278 ↗
• MalfunctionAug 27, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING ON THE HIGH RATE EPISODES. 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 20074247 ↗
• DeathFeb 18, 2022Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS FURTHER REPORTED THAT INTERMITTENT VENTRICULAR CAPTURE OF THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED ON PRESENTING ELECTROGRAMS (EGM) AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RV AND RA LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 13557296 ↗
• MalfunctionDec 18, 2020Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT ATRIAL UNDERSENSING WAS TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035790 ↗
• InjuryJun 25, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNRELIABLE SENSING, UNDER-SENSING, LOW/SMALL P WAVES AND POSSIBLE INAPPROPRIATE TRACKING. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194666 ↗
• MalfunctionJan 3, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. 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 9544716 ↗
• MalfunctionDec 16, 2019Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE SHORT V-V INTERVALS OCCURRED DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473111 ↗
• InjuryApr 30, 2019Over-Sensing; Pacing Problem; High Capture Threshold; Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND OVERSENSING RESULTING IN PACING INHIBITION. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 8563663 ↗
• MalfunctionDec 19, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS UNDERSENSING NOTED ON STORED ELECTROCARDIOGRAMS. 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 8182553 ↗
• MalfunctionSep 26, 2018Under-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 Known Impact Or Consequence To Patient

  MAUDE report 7912180 ↗
• MalfunctionMay 10, 2018Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND UNDERSENSING DURING EPISODES OF VENTRICULAR TACHYCARDIA (VT) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA WHICH OCCURRED DURING MITRAL VALVE REPAIR SURGERY. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS AT A SUBSEQUENT INTERROGATION. 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 7503469 ↗
• InjuryMay 9, 2018Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POST-OPERATIVELY, THE RIGHT ATRIAL (RA) LEAD BECAME DISLODGED AND WAS CONFIRMED BY X-RAY TO BE IN THE RIGHT VENTRICLE. NO CAPTURE WAS EXHIBITED IN THE ATRIUM. THE RA LEAD WAS EXPLANTED 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 7499627 ↗
• InjuryMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS DISLODGED ONE DAY AFTER IMPLANT. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE WAS NOT SUTURED AND MOVED A SIGNIFICANT AMOUNT, WHICH CAUSED THE LEADS TO DISLODGE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE RA LEAD WAS REPOSITIONED AND REMAINS IN USE. THE IPG DEVICE 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 7489166 ↗
• InjuryApr 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF DYSPNEA ON EXERTION, AND FURTHER EXAMINATION REVEALED POSSIBLE POOR BLOOD FLOW ACROSS THE TRICUSPID VALVE DUE TO THE PLACEMENT OF THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Tricuspid Insufficiency

  MAUDE report 7459698 ↗
• MalfunctionApr 10, 2018Failure to Sense; Under-Sensing; Failure to Sense; Under-Sensing

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS NO SENSING ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. IT WAS ALSO REPORTED UPON SLITTING THE PHYSICIAN LOST THE SLITTER ENGAGEMENT OF THE CATHETER. WHEN RE-ENGAGING THE SLITTER AND ATTEMPTING TO SLIT THE CATHETER PORTION CONTAINING THE HUB SLIT OFF AND THERE WAS NO "HANDLE" LEFT TO PULL ON THE CATHETER. ANOTHER CATHETER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416289 ↗
• InjuryApr 10, 2018Device Disinfection Or Sterilization Issue; Device Disinfection Or Sterilization Issue

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VEGETATION. THE LEADS WERE EXTRACTED AND REPLACED WITH A TEMPORARY LEAD. THE DEVICE REMAINS IN USE AND THE SYSTEM WILL BE REPLACED IN THE FUTURE 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 7416184 ↗
• InjuryApr 10, 2018Failure to Capture; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. IT WAS DETERMINED THAT THE LEAD HAD PERFORATED THE PATIENT'S CARDIAC TISSUE RESULTING IN A PERICARDIAL EFFUSION. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 7415208 ↗
• InjuryApr 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE PATIENT THAT THEIR LEAD WAS READJUSTED ONE WEEK AFTER IT WAS IMPLANTED. NO INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP ATTEMPTS WITH THE CLINIC. THE RIGHT ATRIAL (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 7415062 ↗
• InjuryFeb 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING POST IMPLANT, THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE LEAD WAS EXPLANTED 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 7255622 ↗
• MalfunctionFeb 8, 2018Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE LEAD EXHIBITED NOISE AND UNDERSENSING. THE LEAD WAS REMOVED AN AN ALTERNATIVE LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7255099 ↗