CapSureFix MRI SureScanRecalls & reported problems across all models

We found 3 models of CapSureFix MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 5,694 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2012 and Sep 28, 2026 — classified as 37 deaths, 2,641 injuries, 3,016 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (1,822 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CapSureFix MRI SureScan problems

CapSureFix MRI SureScan models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CapSureFix MRI™ SureScan™ 5086MRI52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  18 deaths2,671 reports
• CapSureFix MRI™ SureScan™ 5086MRI45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  10 deaths1,827 reports
• CapSureFix MRI™ SureScan™ 5086MRI58

  Permanent defibrillator electrodes
  9 deaths1,196 reports

Recent CapSureFix MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 28, 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 50913103 ↗
• 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 18, 2026Under-Sensing

  It was reported that the Implantable Pulse Generator (IPG) exhibited a partial electrical reset. The Right Atrial (RA) lead also exhibited under sensing. The IPG and RA 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 50814350 ↗
• MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in the termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events and unnecessary pacing. The RA lead also exhibited an Atrial Lead Position Check failure. 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 50802956 ↗
• 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 17, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The lead remains in u se. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800499 ↗
• MalfunctionSep 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787497 ↗
• MalfunctionSep 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785851 ↗
• InjurySep 14, 2026Intermittent Capture; Capturing Problem

  It was reported that the Right Ventricular (RV) lead exhibited a rise in thresholds and intermittent loss of capture. 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 50756039 ↗
• 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls