CapSureFix Novus MRI™ SureScan® 5076-45 (UDI 00643169633742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16,004 adverse event reports that list this exact device (DI 00643169633742), received between Dec 7, 2017 and Sep 30, 2026 — classified as 136 deaths, 6,456 injuries, 9,412 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (6,249 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 16,004 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 50955129 ↗
• MalfunctionSep 30, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951603 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing; Low impedance; Decreased Sensitivity

  It was reported that the Right Atrial (RA) lead exhibited undersensing on current electrograms (EGM) and stored episode(s) during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and termination of AT/AF detected event(s) in progress. Low P waves were also noted. 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 50950503 ↗
• InjurySep 30, 2026Capturing Problem

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 50949997 ↗
• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949362 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Under-Sensing

  It was reported that during use of the Cardiac Resynchronization Therapy Defibrillator (CRT-D),  the Ventricular Tachycardia (VT) rhythm appears to fall in and out of detection possibly delaying therapy.  At device classified termination of events, arrhythmia appears to continue beneath detection rate.  The CRT-D remains in use.  The Right Atrial (RA) lead, atrial lead position check failed due to an unknown/unspecified reason. It was further reported that another RA lead Atrial Lead Position Check failed and it was due to intermittent and sudden undersensing. The lead remains in use with the physician closely monitoring lead trends. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948182 ↗
• InjurySep 30, 2026Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  It was reported that seven weeks post implant the Right Atrial (RA) lead and Right Ventricular (RV) Left Bundle Branch (LBB) lead dislodged. The RV LBB lead exhibited high thresholds and intermittent capture. The RA lead exhibited no capture and no sensing. The physician was suspicious of Twiddler's Syndrome due to the lack of slack and possible twists in the leads seen on x-ray. Upon opening the pocket, knots were seen in the lead coils, indicating the dislodgement was due to Twiddlers' Syndrome. The RV LBB lead was reprogrammed. The RA lead and RV LBB leads were explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50947851 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing. 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 50947052 ↗
• InjurySep 30, 2026Impedance Problem

  It was reported that post Implantable Pulse Generator (IPG) system implant the patient was not feeling well and was having hypotension that increasingly worsened and they developed shock lock symptoms. A pericardial effusion was discovered and patient was treated for pericardial tamponade. The patient was in Intensive Care Unit (ICU) and intubated. The Right Atrial (RA) lead was noted to have decreased since implant. The IPG system remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Tamponade; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50944817 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing. The RA lead 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 50944598 ↗
• MalfunctionSep 30, 2026High impedance; Impedance Problem

  It was reported that there was a gradual increase in impedance and high impedance on the Right Atrial (RA) lead. 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 50944293 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Over-Sensing

  It was reported that the patient experienced palpitations. It was further reported that the Right Atrial (RA) lead exhibited oversensing and failed a position check. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944156 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported post-operatively that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering Atrial Tac hycardia/Atrial Fibrillation (AT/AF) episode misclassification. 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 50943567 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited  intermittent under sensing on stored episode(s),  resulting in misclassification of Ventricular Tachycardia (VT) episodes and under sensed Atrial Fibrillation (AF). A low P wave amplitude was 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 50943367 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-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 and unnecessary atrial pacing at times. 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 50943291 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and affecting detection of AT/AF events. 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 50943091 ↗
• MalfunctionSep 30, 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 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 50943059 ↗
• InjurySep 29, 2026Under-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933307 ↗
• InjurySep 29, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933039 ↗
• MalfunctionSep 29, 2026Over-Sensing; Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited over sensing in blanking resulting in atrial pacing. It was also reported that the Right Ventricular (RV) lead displayed under sensing and intermittent under sensing at times resulting in over pacing. Both the leads 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 50933021 ↗
• MalfunctionSep 29, 2026Failure to Capture; Electrical /Electronic Property Problem

  It was reported that the Right Atrial (RA) lead exhibited loss of capture and failed an Atrial Lead Position Check (ALPC). 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 50932234 ↗
• MalfunctionSep 29, 2026Low impedance

  It was reported that the Right Atrial (RA) lead exhibited low impedance. 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 50931918 ↗
• MalfunctionSep 29, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited events falling in blanking period with device classified termination of AT/AF detected events and 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 50930587 ↗
• MalfunctionSep 29, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929706 ↗
• MalfunctionSep 29, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing and the Right Atrial (RA) lead exhibited undersensing of Atrial Tachycardia/ Atrial Fibrillation (AT/AF) resulting in termination of AT/AF detected event(s) in progress and unnecessary pacing at times. The RV and 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 50929600 ↗