CapSureFix Novus MRI™ SureScan™ 407645 (UDI 00643169708181)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,370 adverse event reports that list this exact device (DI 00643169708181), received between Jun 8, 2017 and Sep 29, 2026 — classified as 38 deaths, 1,381 injuries, 1,951 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (1,254 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 3,370 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941396 ↗
• MalfunctionSep 29, 2026Failure to Capture

  It was reported that the Right Atrial (RA) and Right Ventricular (RV) leads did not appear to show "proper capture". 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 50933867 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50933781 ↗
• 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 50932261 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930563 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922820 ↗
• MalfunctionSep 28, 2026Under-Sensing

  It was reported that 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. It was also noted that there were low amplitude P waves. 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 50914530 ↗
• InjurySep 28, 2026Electrical /Electronic Property Problem; Device Dislodged or Dislocated

  It was reported that post implant the Right Atrial (RA) lead failed a lead position check and was confirmed to be 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 50914206 ↗
• InjurySep 28, 2026Device Dislodged or Dislocated

  It was reported that post implant the Right Atrial (RA) lead dislodged. The RA lead was revised 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 50913760 ↗
• InjurySep 28, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead was removed and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911487 ↗
• 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 termination of AT/AF detected events 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 50897313 ↗
• MalfunctionSep 25, 2026Low impedance

  It was reported that the Right Atrial (RA) lead exhibited low 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 50897105 ↗
• 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 events in progress and unnecessary 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 50895830 ↗
• MalfunctionSep 24, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing and undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in inappropriate 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 50884042 ↗
• MalfunctionSep 24, 2026Over-Sensing; Activation, Positioning or Separation Problem; High Capture Threshold

  It was reported that during implant, the Right Atrial (RA) lead exhibited high atrial thresholds with large far field r waves noted. It was also reported that the RA lead exhibited jumps during extensions/ retraction. The RA lead was attempted not used and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881406 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50869353 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and leads were 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: Bacteremia

  MAUDE report 50868672 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection and erosion. A skin ulcer was noted at the pocket site. The Implantable Pulse Generator (IPG) system was removed. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Pocket Erosion; Ulcer

  MAUDE report 50866852 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection; Septic Shock; Unspecified Infection

  MAUDE report 50865288 ↗
• MalfunctionSep 23, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress and inappropriate atrial pacing at times. It was further reported that the Right Ventricular (RV) lead exhibited undersensing resulting in possible inappropriate ventricular pacing. 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 50865129 ↗
• MalfunctionSep 18, 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 inappropriate 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 50818339 ↗
• InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient that the Right Atrial (RA) lead was 'not working properly'. It was also reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. The RA lead was capped and replaced. The IPG 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 50817203 ↗
• MalfunctionSep 18, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. 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 50816384 ↗
• MalfunctionSep 17, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing on the atrial lead triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. 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 50799641 ↗
• MalfunctionSep 16, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792819 ↗