CapSureFix Novus MRI™ SureScan™ 407645 (UDI 00763000014636)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00763000014636), received between Feb 8, 2018 and Aug 24, 2026 — classified as 2 deaths, 17 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (21 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 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 events in progress. It was also noted that there were low P waves. 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 50409589 ↗
• MalfunctionNov 6, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING. 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 23484168 ↗
• MalfunctionMay 28, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) WITH SEVENTY SHORT V-V INTERVALS AND HIGH RATE-NON-SUSTAINED (HRNS) EPISODES IN ADDITION TO CHRONIC LOW R-WAVES AND OVERSENSING. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. 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 22099025 ↗
• MalfunctionJan 31, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING ON SOME STORED AND CURRENT ELECTROGRAMS (EGM) AND CURRENT EGM. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER-SENSING ON SOME EGMS. 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 21281831 ↗
• MalfunctionJan 20, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPNEA AND CONGESTIVE HEART FAILURE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF AT/AF EVENT(S) AT TIMES AND APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21189302 ↗
• InjuryJan 10, 2025Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21122685 ↗
• DeathOct 21, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST AFTER MULTIPLE VENTRICULAR FIBRILLATION (VF) EPISODES. A DEVICE INTERROGATION INDICATED RIGHT ATRIAL (RA) LEAD UNDERSENSING. RIGHT VENTRICULAR (RV) LEAD UNDERSENSING WAS ALSO NOTED, POSSIBLY DUE TO MORPHOLOGY. A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RV LEAD DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. THE PATIENT'S FAMILY OPTED WITH WITHDRAW CARE AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT OBTAINED.

  Patient problems: Cardiac Arrest

  MAUDE report 20494155 ↗
• MalfunctionFeb 29, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WHICH RESULTED IN INAPPROPRIATE INTERMITTENT PACING. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF). THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 18810643 ↗
• MalfunctionDec 20, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) 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 18362688 ↗
• MalfunctionOct 23, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL QUESTIONED IF THE HIS BUNDLE LEAD HAD LOSS OF CAPTURE.  IT WAS NOTED THAT SOME FAR FIELD R-WAVE (FFRW) OVERSENSING OF THE RIGHT ATRIAL (RA) LEAD OCCURRED DURING THAT EPISODE.  IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD T-WAVE OVERSENSING (TWOS) FOR EVERY BI-VENTRICULAR PACE.  THE FEATURE THAT MONITORS THE PACING AMPLITUDE THRESHOLD HAD A VARIABLE TREND ON THE HIS BUNDLE LEAD TREND.  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 17987957 ↗
• InjuryOct 10, 2023Fracture; High impedance; Impedance Problem; Appropriate Device Problem Term/Code Not Available; Fracture; High impedance; Impedance Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED INCREASING IMPEDANCE AND HIGH AND UNDEFINED IMPEDANCE. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED A FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904874 ↗
• MalfunctionOct 2, 2023Under-Sensing; Capturing Problem; High Capture Threshold; Under-Sensing; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A SUDDEN INCREASE IN THRESHOLDS, HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED INTERMITTENT UNDER-SENSING, WHICH DID NOT APPEAR TO AFFECT MODE SWITCH. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 17851295 ↗
• InjuryAug 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS PROGRAMMED OFF DUE TO LEAD 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 17600985 ↗
• MalfunctionJun 30, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON PRESENTING ELECTROGRAMS (EGM). 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 17237734 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BACTEREMIA, THEY PRESENTED TO HOSPITAL WITH THREE DAYS OF FEVER, CHILLS, FATIGUE, WEAKNESS, DIARRHEA AND NAUSEA. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Chills; Diarrhea; Fatigue; Fever; Muscle Weakness/Atrophy; Nausea

  MAUDE report 17087305 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A TEMPORARY DEVICE AND LEAD PLACED . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17009277 ↗
• MalfunctionApr 18, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). 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 16761425 ↗
• MalfunctionFeb 23, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING ON ELECTROGRAMS (EGM) THAT DOES NOT AFFECT DEVICE FUNCTION. 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 16425703 ↗
• MalfunctionOct 28, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING NOTED ON CURRENT ELECTROGRAMS (EGM'S) AND POSSIBLY ON SOME 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 15690016 ↗
• DeathFeb 21, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED BRADYCARDIA AND CARDIAC ARREST. 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. IT WAS FURTHER REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST PRIOR TO REPROGRAMMING.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 13567003 ↗
• MalfunctionSep 27, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW LEAD IMPEDANCE WARNING. 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 12531550 ↗
• MalfunctionAug 12, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. 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 12311531 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. CULTURES WERE TAKEN AND TEMPORARY PACING WAS USED. THE SYSTEM WAS REPLACED ON THE CONTRALATERAL SIDE FOUR DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 12085158 ↗
• MalfunctionApr 1, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED 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 11601050 ↗
• MalfunctionOct 20, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA 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 10704828 ↗