CapSureFix Novus MRI™ SureScan® 5076-65 (UDI 00643169550780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00643169550780), received between Dec 9, 2016 and Aug 24, 2026 — classified as 45 injuries, 21 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (17 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a staphylococcus aureus infection and bacteremia was noted. It was noted that the original source/ location of the infection was enterococcus bacteremia. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Endocarditis

  MAUDE report 50407323 ↗
• MalfunctionMay 6, 2026Pacing Problem; Under-Sensing; High Capture Threshold

  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 EVENT(S) IN PROGRESS. HIGH THRESHOLDS AND UNDERSENSING RESULTING IN INAPPROPRIATE PACING WAS ALSO NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. 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 25091075 ↗
• InjuryFeb 18, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE ON CURRENT ELECTROGRAMS (EGM). THE RV LEAD AND RA LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Bradycardia; Chest Pain; Diaphoresis; Discomfort; Dizziness; Dyspnea; No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes; Pain; Palpitations; Presyncope; Syncope/Fainting

  MAUDE report 24375588 ↗
• MalfunctionFeb 13, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA (AT) / ATRIAL FIBRILLATION (AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND FALSE TERMINATION OF EVENTS. 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 24335422 ↗
• InjuryDec 18, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING FALSE TERMINATION OF VT-NS EVENT(S). THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836645 ↗
• MalfunctionNov 25, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A SUDDEN INCREASE IN CAPTURE THRESHOLDS AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED PACING IMPEDANCE. THE RA LEAD AND RV 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 23646382 ↗
• InjuryOct 23, 2025Mechanical Problem; Capturing Problem; Impedance Problem; High Capture Threshold; Mechanical Problem; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING HIGH THRESHOLDS HAD A DROP IN IMPEDANCE AND AN INSULATION BREACH. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365230 ↗
• InjuryJul 4, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED SHORT V-V INTERVALS ON SENSING INTEGRITY COUNTER (SIC). 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 22403392 ↗
• MalfunctionMar 3, 2025Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502780 ↗
• InjuryJun 6, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPROGRAMMED AND 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 19478211 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE LEAD WAS RETURNED, ANALYZED AND TESTED OUT-OF-SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086018 ↗
• InjuryFeb 12, 2024Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE RV LEAD HAD BECOME DISLODGED. THE RV LEAD WAS CAPPED 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 18683936 ↗
• InjuryDec 20, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNIPOLAR AND BIPOLAR IMPEDANCE AND A FRACTURE WAS CONFIRMED. THE PHYSICIAN NOTICED A SUTURE TIED AROUND THE LEAD ONCE THEY OPENED THE PATIENT UP AND SAW INSIDE THE POCKET. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362300 ↗
• MalfunctionDec 6, 2023High impedance; Over-Sensing; Capturing Problem; High impedance; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE IN THE RANGE OF THIRTY TO FORTY BEATS PER MINUTE. ON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED BIPOLAR AND UNIPOLAR WARNINGS FOR HIGH IMPEDANCE. THE RV LEAD ALSO EXHIBITED SHORT VENTRICLE TO VENTRICLE (V-V) INTERVALS. THE PHYSICIAN REPORTED QUESTIONABLE RV LEAD CAPTURE ON CURRENT ELECTROGRAM. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18274447 ↗
• InjurySep 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PACING LEAD EXHIBITED A MALFUNCTION. 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 17823122 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF). INTRA OPERATIVE THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE RV AND RIGHT ATRIAL (RA) LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 17485937 ↗
• MalfunctionJul 26, 2023Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IT WAS FURTHER REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE ON PRESENTING AND STORED ELECTROGRAMS (EGM) AND HIGH THRESHOLDS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 17395758 ↗
• InjuryMay 16, 2023Intermittent Capture; Fracture; Capturing Problem; Impedance Problem; High Capture Threshold; Intermittent Capture; Fracture; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NUMBER OF FALLS AND DIZZINESS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE F RACTURE, HIGH AND RISING THRESHOLDS, INTERMITTENT LOSS OF CAPTURE AND RISING AND UNSTABLE IMPEDANCES. THE RV LEAD WAS REPROGRAMMED OFF AS DUE TO OCCLUSION A REPLACEMENT LEAD WAS NOT POSSIBLE. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED WITH THE OLD IPG PROGRAMMED AAIR. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Fall; Obstruction/Occlusion

  MAUDE report 16937639 ↗
• InjuryMar 2, 2023Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCES AND A LOSS OF CAPTURE AT MAXIMUM OUTPUTS. A LEAD FRACTURE WAS SUSPECTED, AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469810 ↗
• InjuryOct 20, 2022High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED RISING IMPEDANCE AND HIGH AND UNDEFINED IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638120 ↗
• InjuryOct 14, 2022Failure to Capture; Fracture; Failure to Capture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED TO CAPTURE. IT WAS ALSO NOTED THAT THE RV LEAD WAS FRACTURED. THE RV LEAD WAS CAPPED 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 15604793 ↗
• InjuryAug 15, 2022Adverse 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 AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15223214 ↗
• InjuryJun 2, 2022Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing; Pacing Problem; Low impedance; Device Sensing Problem; Impedance Problem; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Over-Sensing; Pacing Problem; Low impedance; Device Sensing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT A POLARITY SWITCH WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. HIGH THRESHOLDS AND NO CAPTURE IN BOTH CONFIGURATIONS AND HIGH IMPEDANCE WERE ALSO NOTED.  ISOMETRICS PRODUCED OVERSENSING OF SHORT V-V INTERVALS AND NOISE FOLLOWED BY INHIBITION OF RIGHT ATRIAL (RA) AND RV PACING. A POSSIBLE LEAD FRACTURE WAS NOTED.  THE LEAD WAS REPROGRAMMED OFF AND LATER CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14571855 ↗
• MalfunctionFeb 9, 2022Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE R-WAVE AMPLITUDE WAS NOTED TO BE TRENDING DOWNWARDS ON LEAD TRENDS. 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 13494684 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. ANTIBIOTICS WERE USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13366452 ↗