CapSureFix Novus MRI™ SureScan® 5076-65 (UDI 00643169448919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169448919), received between Dec 9, 2016 and Aug 10, 2026 — classified as 7 injuries, 4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported approximately one month post generator changeout, the patient developed a pocket infection and erosion. The IPG system, including the leads, were explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50192157 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23645708 ↗
• MalfunctionDec 1, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) 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 18246986 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYSTEMIC INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A BI-VENTRICULAR DEFIBRILLATOR SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15788861 ↗
• MalfunctionJan 21, 2022Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 13314082 ↗
• MalfunctionApr 23, 2021Failure to Capture; Pacing Problem; Under-Sensing; Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH PRESYNCOPE AND SHORTNESS BREATH. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 11715921 ↗
• InjuryJun 17, 2019Signal Artifact/Noise; High Capture Threshold; Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NOISE. 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 8703061 ↗
• InjuryFeb 7, 2019High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. IT WAS ALSO NOTED THAT THERE WAS OVERSENSING ON THE RV LEAD. THE RV LEAD WAS CAPPED 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 8317769 ↗
• MalfunctionMay 15, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED BY THE PATIENT THAT NOISE WAS SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. 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 7514115 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO BACTERIMIC INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 7414008 ↗
• InjuryDec 9, 2016Failure to Capture; Decreased Sensitivity; Capturing Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Failure to Capture; Decreased Sensitivity; Capturing Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ONE DAY AFTER IMPLANT THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD SHOWED RISING PACING THRESHOLD, REDUCED SENSING, AND PHRENIC NERVE STIMULATION. IT WAS REPORTED THAT THE RV LEAD HAD LIKELY PERFORATED AND THE RV LEAD WAS REPOSITIONED. FOUR DAYS LATER THERE WAS LOSS OF PACING CAPTURE AND AN X-RAY CONFIRMED ANOTHER PERFORATION. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Hiccups

  MAUDE report 6160872 ↗