CapSureFix Novus MRI™ SureScan® 5076-35 (UDI 00643169448872)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169448872), received between Feb 8, 2018 and Aug 27, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE NOTED ON EXTERNAL TELEMETRY, WITH PATIENT HEART RATE INTO THE FORTIES. IT WAS FOUND THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED END OF SERVICE (EOS). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED A VARIATION AND AN INCREASE IN LEAD IMPEDANCES NOTED ON LEAD TRENDS AND ATRIAL CAPTURE COULD NOT BE CONFIRMED. THE IPG WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22903375 ↗
• MalfunctionAug 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS NOTED THAT THERE WAS A HIGH V-V COUNT ON THE RIGHT VENTRICULAR (RV) LEAD AND A FAILED LEAD POSITION CHECK ON THE RIGHT ATRIAL (RA) LEAD. THE RA AND RV 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

  MAUDE report 20074495 ↗
• MalfunctionNov 20, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT 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 18171412 ↗
• MalfunctionJul 26, 2023Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. 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 17395192 ↗
• MalfunctionJun 2, 2023Under-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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17051344 ↗
• MalfunctionApr 7, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED OVERSENSING OF ARTEFACT ON STORED ELECTROGRAMS (EGM). IT WAS FURTHER REPORTED THAT THERE WAS LOW MEASURED R WAVES. 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 16699853 ↗
• MalfunctionAug 13, 2021Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDER SENSING OF SMALLER ATRIAL SIGNALS DURING RAPID ATRIAL RHYTHMS ON STORED ELECTROGRAMS (EGM). THE 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 12317769 ↗
• MalfunctionAug 29, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT UNDERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA / ATRIAL FIBRILLATION (AF) EPISODES 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 Known Impact Or Consequence To Patient

  MAUDE report 8943757 ↗
• MalfunctionFeb 8, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT A REMOTE TRANSMISSION INDICATED POSSIBLE INTERMITTENT ATRIAL LEAD UNDERSENSING DURING A MONITORED VENTRICULAR TACHYCARDIA EPISODE. 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 7257585 ↗