CapSure Sense MRI SureScanRecalls & reported problems across all models

We found 8 models of CapSure Sense MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,913 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2017 and Sep 30, 2026 — classified as 39 deaths, 1,975 injuries, 1,899 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (1,263 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 CapSure Sense MRI SureScan problems

CapSure Sense MRI SureScan models

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

• CapSure Sense MRI™ SureScan™ 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  16 deaths1,416 reports
• CapSure Sense MRI™ SureScan™ 457453

  Permanent defibrillator electrodes
  7 deaths961 reports
• CapSure Sense MRI™ SureScan™ 407458

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths766 reports
• CapSure Sense MRI™ SureScan™ 407452

  permanent pacemaker Electrode
  8 deaths699 reports
• CapSure Sense MRI™ SureScan™ 407452

  Permanent defibrillator electrodes
  28 reports
• CapSure Sense MRI™ SureScan™ 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  15 reports
• CapSure Sense MRI™ SureScan™ 457453

  Permanent defibrillator electrodes
  14 reports
• CapSure Sense MRI™ SureScan™ 407458

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  14 reports

Recent CapSure Sense MRI SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The lead was explanted and replaced. No patient comp lications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947427 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket 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 50945978 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket infection. The Implantable Pulse Generator (IPG) sysetm was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50945880 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes resulting in termination of AT/AF detected event(s) in progress. 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 50945078 ↗
• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that post Implantable Pulse Generator (IPG) system implant the patient was not feeling well and was having hypotension that increasingly worsened and they developed shock lock symptoms. A pericardial effusion was discovered and patient was treated for pericardial tamponade. The patient was in Intensive Care Unit (ICU) and intubated. The Right Atrial (RA) lead was noted to have decreased since implant. The IPG system remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Tamponade; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50944868 ↗
• InjurySep 30, 2026Failure to Capture; Electrical /Electronic Property Problem; High impedance; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited no capture, high thresholds, a polarity switch and, spikes in impedance,  high undefined impedances. The RV 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 50944786 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited occasional undersensing resulting in unnecessary pacing at times. 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 50942868 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited oversensing, noise, high impedance, rising impedance, polarity switch and 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 50930548 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead triggered multiple alerts for high RV defibrillation impedance. The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. 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 50921549 ↗
• MalfunctionSep 28, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917053 ↗
• MalfunctionSep 28, 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 50913632 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a Leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50911594 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50895766 ↗
• MalfunctionSep 25, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia (AT)/Atrial Fibrillation (AF) stored episodes ,  resulting in termination of AT/AF detected event(s) in progress. 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 50894558 ↗
• InjurySep 23, 2026Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising and high thresholds. 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 50868967 ↗

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