CapSureFix Novus MRI™ SureScan™ 407652 (UDI 00643169708198)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,097 adverse event reports that list this exact device (DI 00643169708198), received between Jun 8, 2017 and Sep 30, 2026 — classified as 69 deaths, 2,959 injuries, 3,069 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (1,850 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 6,097 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Atrial (RA) lead was removed and replaced 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 50946342 ↗
• MalfunctionSep 30, 2026Failure to Capture; Pacing Problem

  It was reported that there was a loss of capture and pacing issue on the Right Ventricular (RV) lead. 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 50944457 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds and a failed Atrial Lead Position Check. It was also reported the Right Ventricular (RV) lead exhibited changes in sensing and capture thresholds. 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 50944425 ↗
• MalfunctionSep 30, 2026Failure to Capture

  It was reported that the Right Atrial (RA) lead exhibited loss of capture. 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 50943723 ↗
• MalfunctionSep 30, 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 50943023 ↗
• MalfunctionSep 29, 2026Positioning Problem

  It was reported that the customer called to inquire about a sensation they were experiencing with their implanted Implantable Cardioverter Defibrillator (ICD), specifically feeling as though the device had turned or the wires were positioned differently than before. The customer was concerned about whether this was normal and if it could affect the device functionality. The Implantable Cardioverter Defibrillator (ICD) system remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50936040 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50933981 ↗
• MalfunctionSep 29, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933844 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 50932585 ↗
• MalfunctionSep 29, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing on stored episodes, resulting in misclassification of Ventricular Tachycardia-Non sustained (VT-NS) episode. 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 50932042 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) lead were removed and replaced 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 50930565 ↗
• MalfunctionSep 29, 2026Impedance Problem

  It was reported that the Right Atrial (RA) lead exhibited an increasing impedance trend. 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 50928911 ↗
• MalfunctionSep 28, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914858 ↗
• MalfunctionSep 28, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The lead remains in use. No patient c omplications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913384 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 50913017 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing on the atrial lead during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. 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 50912931 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-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 causing inappropriate atrial pacing. 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 50911141 ↗
• MalfunctionSep 25, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in the termination of AT/AF detected events 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 50896257 ↗
• MalfunctionSep 25, 2026Pacing Problem; Under-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 and unnecessary pacing at times. 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 50895751 ↗
• MalfunctionSep 25, 2026Capturing Problem

  It was reported that the Right Atrial (RA) lead exhibited increased 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 50895687 ↗
• MalfunctionSep 25, 2026Capturing Problem

  It was reported that the Left Bundle Branch (LBB) Right Ventricular (RV) lead and Right Atrial (RA) lead both exhibited a gradual rise increase in thresholds. Both 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 50894482 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to a mobile echogenic mass/vegetation attached to the Right Atrial (RA) lead. It was noted that the patient also experienced discomfort. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Medical device site infection

  MAUDE report 50882025 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported that the Right Ventricular (RV) lead became dislodged. The RV 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 50881351 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported that the Right Atrial (RA) lead dislodged. The patient was hospitalised and 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 50880573 ↗
• MalfunctionSep 24, 2026Impedance Problem; Unstable Impedance

  It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) lead exhibited rising and fluctuating unipolar impedance which appeared to be consistent with a Implantable Pulse Generator (IPG) or measurement-related issue. The IPG system 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 50879901 ↗