CAPSURE SENSERecalls & reported problems across all models

We found 12 models of CAPSURE SENSE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,345 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2013 and Sep 29, 2026 — classified as 13 deaths, 647 injuries, 685 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (444 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 problems

CAPSURE SENSE models

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

• CAPSURE® SENSE 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death300 reports
• CapSure Sense® 457445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  202 reports
• CAPSURE® SENSE 457453

  Permanent defibrillator electrodes
  2 deaths198 reports
• CAPSURE® SENSE 407452

  permanent pacemaker Electrode
  4 deaths181 reports
• CAPSURE® SENSE 407458

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths151 reports
• CapSure Sense® 457453

  permanent pacemaker Electrode
  1 death110 reports
• CapSure Sense® 407452

  Permanent defibrillator electrodes
  2 deaths72 reports
• CapSure Sense® 407458

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  57 reports
• CapSure Sense® 407452

  permanent pacemaker Electrode
  35 reports
• CapSure Sense® 407458

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  34 reports
• CAPSURE® SENSE 407352

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• CAPSURE® SENSE 407445

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 report

Recent CAPSURE SENSE adverse event reports

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

• InjurySep 29, 2026Failure to Capture

  It was reported that the patient experienced syncope. The Right Ventricular (RV) lead capture could not be confirmed as the Implantable Pulse Generator (IPG) had reached Recommended Replacement Time (RRT). The RV lead remains in use. The IPG was explanted and replaced as it had reached normal Elective Replacement Indicator (ERI). No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50933101 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  It was reported that the patient experienced an arrhythmia. The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Arrhythmia

  MAUDE report 50912520 ↗
• MalfunctionSep 23, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871297 ↗
• MalfunctionSep 18, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing during detected arrhythmia episodes and suspected during detected ventricular sensing episodes. It was also reported that the Right Atrial (RA) lead exhibited undersensing. 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 50821007 ↗
• MalfunctionSep 14, 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 50752151 ↗
• MalfunctionAug 31, 2026Under-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521161 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the pacing system was explanted and replaced due to infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50324191 ↗
• InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Ventricular (RV) lead was capped and a new lead placed a couple of years ago with no information provided on the reason for replacement. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50154491 ↗
• InjuryJul 1, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE LOW IMPEDANCE AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ST ORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS, LACK OF DETECTION OF AT/AF, AND INAPPROPRIATE PACING. IT WAS ALSO NOTED THAT THERE WERE LOW AMPLITUDE P WAVES. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25678363 ↗
• MalfunctionJun 12, 2026Under-Sensing

  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. LOW P WAVES NOTED. 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 25492789 ↗
• InjuryJun 10, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD UNDERSENSING RESULTING IN INAPPROPRIATE PACING DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NS-VT) EPISODES. THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25454762 ↗
• MalfunctionJun 5, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED A WARNING FOR HIGH/UNDEFINED IMPEDANCE. 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 25408545 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AFTER THE PATIENT WAS PROGRAMMED TO AN MAGNETIC RESONANCE IMAGING (MRI) SAFE MODE, THE PATIENT EXPERIENCED DISCOMFORT, AN ELEVATED HEART RATE, DID NOT FEEL WELL, AND FELT "FLUSHED". THE PATIENT WAS HOSPITALIZED AND REPROGRAMMED OUT OF THE MRI SAFE MODE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 25390870 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AFTER THE PATIENT WAS PROGRAMMED TO AN MAGNETIC RESONANCE IMAGING (MRI) SAFE MODE, THE PATIENT EXPERIENCED DISCOMFORT, AN ELEVATED HEART RATE, DID NOT FEEL WELL, AND FELT "FLUSHED". THE PATIENT WAS HOSPITALIZED AND REPROGRAMMED OUT OF THE MRI SAFE MODE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 25390868 ↗
• MalfunctionJun 2, 2026Under-Sensing

  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. 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 25362240 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
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• 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