CapSure Sense MRI™ SureScan™ 457453 (UDI 00643169410947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 961 adverse event reports that list this exact device (DI 00643169410947), received between Jun 8, 2017 and Sep 25, 2026 — classified as 7 deaths, 426 injuries, 528 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (390 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 961 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 16, 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 events in progress and misclassification of AT/AF events as Ventricular Tachycardia (VT)-Non-Sustained events. 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 50789038 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection

  MAUDE report 50780898 ↗
• MalfunctionSep 15, 2026Failure to Capture; Electrical /Electronic Property Problem

  It was reported that the Right Atrial (RA) lead exhibited possible loss of capture on current electrograms (EGM). It was also reported that the RA lead exhibited an Atrial Lead Position Check fail. 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 50773578 ↗
• MalfunctionSep 15, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. 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 50772499 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in overpacing. It was also reported that the RA lead exhibited Atrial lead position check (ALPC) 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 50767864 ↗
• MalfunctionSep 14, 2026Under-Sensing

  It was reported that postoperatively 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 com plications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751042 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to endocarditis. An Implantable Pulse Generator (IPG) system was implanted on the opposite side of the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis

  MAUDE report 50675509 ↗
• MalfunctionSep 8, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674185 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that the Right Atrial (RA) lead dislodged. 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 50611219 ↗
• MalfunctionSep 2, 2026Electrical /Electronic Property Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559242 ↗
• MalfunctionSep 1, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539965 ↗
• InjurySep 1, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539951 ↗
• MalfunctionAug 31, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519992 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection, purulent discharge/pus, redness, swelling and wound dehiscence. The health professional assessed that use of the arm to use a wheelchair possibly resulted in would dehiscence leading to infection. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless IPG system. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50519707 ↗
• InjuryAug 31, 2026Device Dislodged or Dislocated

  It was reported that approximately a month post implant the Right Atrial (RA) lead had dislodged. 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 50517574 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and fever. Staphylococcus aureus noted. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 50494444 ↗
• InjuryAug 27, 2026Over-Sensing; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that on the same day as implant the Right Atrial (RA) lead dislodged into the ventricle. Elevated thresholds and Far Field R-Wave (FFRW) oversensing were also noted. The RA lead was remove and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474797 ↗
• MalfunctionAug 27, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited high impedance. 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 50473484 ↗
• InjuryAug 25, 2026Decreased Sensitivity; High Capture Threshold

  It was reported that the Right Atrial (RA) lead and the Right Ventricular Left Bundle Branch (RV-LBB) lead exhibited diminished sensing and increased thresholds. The RA and RV-LBB 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 50431135 ↗
• InjuryAug 24, 2026High Capture Threshold

  It was reported that the patient presented to the Emergency Room with Ventricular Tachycardia (VT). Upon interrogation of the Cardiac Resynchronization Therapy Defibrillator (CRT-D); there were no electrograms (EGMs) present for transmissions or programmer checks. In addition, the Right Atrial (RA) lead exhibited high atrial thresholds. The patient was admitted to the hospital. The CRT-D continued to exhibit a lack of useful diagnostic information. There were stored arrhythmias but no EGMs. The CRT-D remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50419434 ↗
• MalfunctionAug 20, 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 in progress and possible misclassification of episode detection. 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 50343378 ↗
• InjuryAug 20, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported approximately two months post implant, the Right Atrial (RA) lead began to exhibit high thresholds. The lead was found to have dislodged. 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 50343103 ↗
• MalfunctionAug 18, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296789 ↗
• MalfunctionAug 18, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50294361 ↗