CapSureFix MRI™ SureScan™ 5086MRI52Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,671 adverse event reports that list this exact device (DI 00613994657367), received between Oct 15, 2012 and Sep 28, 2026 — classified as 18 deaths, 1,287 injuries, 1,366 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (782 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 2,671 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited noise and oversensing resulting in misclassification of episode type. 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 50915864 ↗
• MalfunctionSep 25, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. 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 50894330 ↗
• MalfunctionSep 18, 2026Under-Sensing

  It was reported that Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate ventricular pacing. 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 50818340 ↗
• MalfunctionSep 17, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead had failed an Atrial Lead Position Check. It was also reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The 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 50800764 ↗
• MalfunctionSep 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787497 ↗
• MalfunctionSep 14, 2026Intermittent Capture; High impedance; Over-Sensing; Low impedance; Impedance Problem

  It was reported that the Right Ventricular (RV) lead exhibited rising, high and low impedance, a high Sensing Integrity Counter (SIC) count, and intermittent capture. 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 50750785 ↗
• MalfunctionSep 11, 2026High impedance

  It was reported that the Right Atrial (RA) lead triggered an alert for Out of Range (OOR) high impedance. 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 50731456 ↗
• MalfunctionSep 10, 2026Impedance Problem

  It was reported that the Right Ventricular (RV) lead triggered an alert for undefined impedance. 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 50717179 ↗
• MalfunctionSep 10, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. 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 50715210 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency department with sceptic shock due to Methicillin-resistant Staphylococcus aureus bacteremia, requiring vasopressor administration. Transesophageal Echocardiography (TEE) confirmed vegetation on the Right Ventricular (RV) lead and Right Atrial (RA) lead. Computerized tomography (CT) scan could not discern if the patient was experiencing pneumonia or sceptic pulmonary emboli. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Medical device site infection; Pneumonia; Pulmonary Embolism; Septic Shock

  MAUDE report 50691951 ↗
• InjurySep 9, 2026Signal Artifact/Noise

  It was reported that both the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited noise. Both leads were 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 50689428 ↗
• MalfunctionSep 8, 2026Failure to Capture; Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture and undersensing resulting in misclassification of arrhythmia episode type and unnecessary pacing. 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 50665179 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562488 ↗
• MalfunctionSep 2, 2026High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559243 ↗
• MalfunctionAug 31, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518863 ↗
• InjuryAug 28, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. 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 50495712 ↗
• InjuryAug 26, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing and noise resulting in the misclassification of episode types. It was noted that the patient experienced dizziness and syncope. It was also reported that the RA lead triggered a warning for high, undefined pacing impedances. The RA lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 50459689 ↗
• InjuryAug 26, 2026High Capture Threshold; Unstable Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high and unstable thresholds. In addition, the Right Atrial (RA) lead exhibited low impedance and noise. Both leads were 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 50454979 ↗
• MalfunctionAug 25, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing on a stored Atrial Tachycardia/Atrial Fibrillation (AT/AF) episode, resulting in termination of the AT/AF detected event in progress and inappropriate pacing. 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 50434382 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited over sensing, resulting in misclassification of episode type. It was reported that the Right Ventricular (RV) lead exhibited over sensing, resulting in misclassification of episode type. Both leads exhibited noise. 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 50341935 ↗
• MalfunctionAug 19, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323918 ↗
• InjuryAug 19, 2026Fracture; High impedance; Unstable Capture Threshold

  It was reported that the Right Ventricular (RV) lead had a suspected fractured and exhibited high impedance and unstable thresholds. 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 50321239 ↗
• InjuryAug 19, 2026Fracture

  It was reported that the Right Ventricular (RV) lead was fractured. The RV lead was inactivated and remains in the patient. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50319590 ↗
• MalfunctionAug 17, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under-sensing. 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 50271583 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced erosion on the pocket leading to erosion and infection on the leads. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50232605 ↗