CapSureFix Novus MRI™ SureScan® 5076-35 (UDI 00643169550742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169550742), received between Jul 23, 2019 and Jun 2, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Under-Sensing; Decreased Sensitivity; Signal Artifact/Noise; Fracture; Over-Sensing; Under-Sensing; Decreased Sensitivity

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS NOT WORKING AND EXHIBITED A FRACTURE. THE RA LEAD EXHIBITED A FRACTURE WITH NOISE AND IMPEDANCE WARNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052243 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND WAS FOUND TO HAVE A LARGE VEGETATION GROWING ON TRICUSPID EXTENDING INTO THE ATRIUM NOT ATTACHED TO THE LEADS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITH NEW LEAD BEING IMPLANTED AND THE EXISTING IPG BEING USED EXTERNALLY. THE SYSTEM WAS THEN REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13756519 ↗
• MalfunctionOct 18, 2021High impedance; Under-Sensing; Decreased Sensitivity; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Under-Sensing; Decreased Sensitivity; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/INCREASED THRESHOLD, HIGH/RISING IMPEDANCE, UNDERSENSING AND LOW R WAVES. 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 12646742 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET EROSION AT THE IMPLANT SITE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD AND SUBSEQUENT LEADS HAVE BEEN EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 9933880 ↗
• MalfunctionJul 23, 2019Under-Sensing; 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 Known Impact Or Consequence To Patient

  MAUDE report 8815295 ↗