CapSureFix Novus MRI™ SureScan™ 407658 (UDI 00643169708204)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,539 adverse event reports that list this exact device (DI 00643169708204), received between Aug 9, 2017 and Sep 30, 2026 — classified as 33 deaths, 927 injuries, 579 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (267 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 1,539 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Capturing Problem; Device Sensing Problem

  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 50944461 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing. 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 50943047 ↗
• MalfunctionSep 29, 2026Decreased Sensitivity

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929709 ↗
• MalfunctionSep 28, 2026Low impedance

  It was reported approximately six months post implant that the Right Ventricular (RV) lead exhibited a warning for low 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 50911226 ↗
• MalfunctionSep 25, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Ventricular (RV) lead exhibited a broken wire. 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 50896967 ↗
• 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 50879926 ↗
• InjurySep 23, 2026High impedance; High Capture Threshold

  It was reported that there was high impedance and intermittent high thresholds on the Right Ventricular (RV) lead. The RV lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869371 ↗
• MalfunctionSep 18, 2026Appropriate Device Problem Term/Code Not Available

  The patient reported that they hadn't felt well for a year. They reported that they experienced palpitations and dizziness. They reported that there was "an issue with one of the leads." The Implantable Pulse Generator (IPG) and Right Ventricular (RV) 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 50816544 ↗
• InjurySep 14, 2026Fracture

  It was reported that the patient experienced bradycardia and dizziness. It was further reported that the Right Ventricular (RV) lead was fractured. The lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dizziness; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752791 ↗
• InjurySep 11, 2026High impedance; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high impedance and high thresholds. The lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728687 ↗
• MalfunctionSep 10, 2026Failure to Capture; High Capture Threshold

  It was reported approximately two weeks after implant that the patient experienced chest pain and bradycardia. The Right Ventricular (RV) lead exhibited no capture and high thresholds. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Chest Pain

  MAUDE report 50712625 ↗
• InjurySep 9, 2026High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the patient experienced chest pain and shortness of breath. It was also reported that the Right Ventricular (RV) lead exhibited rising thresholds, high thresholds, high and undefined impedance and a spike in impedance. The RV lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689667 ↗
• MalfunctionSep 3, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591225 ↗
• MalfunctionSep 1, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542243 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and bacteremia. 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: Bacteremia; Unspecified Infection

  MAUDE report 50516485 ↗
• MalfunctionAug 31, 2026Capturing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516438 ↗
• MalfunctionAug 28, 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 along with Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. Both the RA and 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 50497048 ↗
• MalfunctionAug 26, 2026Decreased Sensitivity

  It was reported that the patient experienced a fall. It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. It was also reported that the Right Ventricular (RV) lead exhibited a drop in R waves. Both leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Fall

  MAUDE report 50453711 ↗
• MalfunctionAug 25, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing.  The Right Ventricular (RV) lead exhibited out of range impedance. 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 50431689 ↗
• MalfunctionAug 24, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing which resulted 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 50403022 ↗
• MalfunctionAug 24, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under-sensing on stored electrograms (EGM), resulting in inappropriate 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 50402226 ↗
• MalfunctionAug 24, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing and misclassification of episode detection. 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 50401616 ↗
• MalfunctionAug 14, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250804 ↗
• MalfunctionAug 14, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate 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 50250662 ↗
• MalfunctionAug 14, 2026Under-Sensing

  It was reported that there was intermittent under sensing on the Right Ventricular (RV) lead. It was also noted there was undersensing on the Right Atrial (RA) lead during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. The RA lead and 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 50250494 ↗