CapSure Sense MRI™ SureScan™ 407458 (UDI 00643169448865)Recalls & reported problems

Summary

The FDA's MAUDE database contains 766 adverse event reports that list this exact device (DI 00643169448865), received between Aug 9, 2017 and Sep 30, 2026 — classified as 8 deaths, 471 injuries, 287 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (215 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 766 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection. Staphylococcus aureus and redness was noted. The Right Ventricular (RV) lead was explanted and replaced with a leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Erythema; Medical device site infection; Unspecified Infection

  MAUDE report 50785648 ↗
• MalfunctionSep 15, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing which resulted in over 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 50775970 ↗
• MalfunctionSep 14, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing. 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 50752947 ↗
• InjurySep 11, 2026Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing; Device Dislodged or Dislocated

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture, dislodgement, oversensing and under sensing resulting in inappropriate pacing, and pre-termination of ventricular arrhythmia. The lead was repositioned 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 50728610 ↗
• MalfunctionSep 3, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate 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 50589287 ↗
• MalfunctionSep 1, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539972 ↗
• InjuryAug 26, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The RV lead was capped 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 50452872 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50278400 ↗
• InjuryJul 29, 2026Device Dislodged or Dislocated

  It was reported that the patient experienced bradycardia. The Right Ventricular (RV) lead exhibited dislodgement. 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: Bradycardia

  MAUDE report 50077655 ↗
• MalfunctionJul 27, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016875 ↗
• MalfunctionJul 20, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25869964 ↗
• InjuryJul 9, 2026Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT ONE WEEK POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DISLODGEMENT AND HIGH THRESHOLDS. THE LEAD WAS REPOSITIONED 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 25759835 ↗
• MalfunctionJul 7, 2026Electrical /Electronic Property Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND A POLARITY SWITCH. 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 25731171 ↗
• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A FRACTURE AND OVERSENSING. THE RA LEAD WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING REPLACED DUE TO MEDICAL JUDGMENT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689421 ↗
• InjuryJun 24, 2026Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING IMPEDANCE ALONG WITH HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED AS PART OF THE SYSTEM UPGRADE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25615762 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, FEVER AND SWELLING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITH NO REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 25577511 ↗
• MalfunctionJun 18, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN PRE-TERMINATION OF AT/AF DETECTED. 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 25544402 ↗
• MalfunctionJun 16, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PACING LEAD WAS OPENED/ NOT USED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515899 ↗
• MalfunctionJun 15, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SPIKE IN BIPOLAR IMPEDANCE. 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 25499464 ↗
• MalfunctionJun 11, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25467713 ↗
• MalfunctionJun 10, 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 25455324 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN 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 25443461 ↗
• MalfunctionJun 5, 2026Capturing Problem

  IT WAS REPORTED THAT THERE WAS A RISE IN RV (RIGHT VENTRICULAR) CAPTURE THRESHOLD. 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 25418134 ↗
• MalfunctionMay 28, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ALONG WITH UNNECESSARY PACING AT TIMES AND INAPPROPRIATE PACING AT TIMES. THE PATIENT EXPERIENCED DIZZINESS/NEAR SYNCOPE. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Presyncope

  MAUDE report 25316042 ↗