CapSureFix Novus MRI™ SureScan® 5076-85 (UDI 00643169633780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169633780), received between Jan 15, 2020 and Aug 10, 2026 — classified as 1 death, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

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

  It was further reported via the clinic that the physician did not puncture the patient's lung.

  Patient problems: Pneumothorax

  MAUDE report 50194140 ↗
• InjuryDec 4, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARYING IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716002 ↗
• MalfunctionJul 26, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE UNDERSENSING POST-THERAPY. 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 19839890 ↗
• MalfunctionFeb 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A FAILED LEAD POSITION CHECK. 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 18748983 ↗
• MalfunctionMay 2, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE ON CURRENT AND 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 16852553 ↗
• MalfunctionApr 7, 2023High impedance; High impedance

  IT WAS REPORTED THAT SIX DAYS POST RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT, THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOXEMIA. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A LEAD WARNING FOR HIGH UNDEFINED IMPEDANCE. THE IPG AND RV LEAD REMAIN 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 16700304 ↗
• InjuryAug 5, 2022Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Capturing Problem; Device Dislodged or Dislocated; Impedance Problem; Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Capturing Problem; Device Dislodged or Dislocated; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS SUSPECTED FOR DISLODGEMENT AS CAPTURE COULD NOT BE CONFIRMED. HIGH AND UNDEFINED UNIPOLAR AND BIPOLAR IMPEDANCE WAS ALSO NOTED WHICH CONTRIBUTED TO A POLARITY SWITCH. NOISE WAS ALSO OBSERVED. 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 15173032 ↗
• DeathAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENTS WIFE THAT THE PATIENT IS DECEASED DUE TO COMPLICATIONS OF HEART FAILURE AND A MAJOR INFECTION.

  Patient problems: Heart Failure/Congestive Heart Failure; Unspecified Infection

  MAUDE report 12300901 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Impedance Problem; Unstable Capture Threshold; Device Dislodged or Dislocated; Impedance Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT AFTER IMPLANT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSTABLE THRESHOLDS AND IMPEDANCES. A LEAD DISLODGEMENT WAS CONFIRMED BY X-RAY. THE RV LEAD WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216199 ↗
• InjuryMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POST OPERATIVELY THE RIGHT ATRIAL (RA) LEAD EXHIBITED DISLODGEMENT. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581033 ↗
• InjuryApr 29, 2020Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10008775 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9590423 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9590406 ↗