CapSureFix Novus MRI™ SureScan® 5076-58 (UDI 00643169550773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,015 adverse event reports that list this exact device (DI 00643169550773), received between Oct 6, 2016 and Sep 30, 2026 — classified as 40 deaths, 1,694 injuries, 1,281 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (640 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 3,015 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the Right Atrial (RA) lead exhibited oversensing and a mirrored artifact possibly due to an insulation breach on the Right Ventricular (RV) lead. This resulted in frequent mode switching to DDIR. 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 50946613 ↗
• MalfunctionSep 29, 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 50930625 ↗
• InjurySep 28, 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 and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50917588 ↗
• InjurySep 24, 2026Fracture; High impedance; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds, high impedance and was fractured. 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 50880736 ↗
• MalfunctionSep 23, 2026Positioning Problem

  It was reported by the patient that their pacing leads migrated from behind the Implantable Pulse Generator (IPG) up to their clavicle. 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 50872347 ↗
• InjurySep 15, 2026Intermittent Capture; Impedance Problem; Unstable Capture Threshold

  It was reported that the patient experienced bradycardia. It was further reported that the Right Ventricular (RV) lead exhibited unstable thresholds, intermittent capture and increased impedance. The lead was capped and replaced. No patient complications have been reported as a result of this event.

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

  MAUDE report 50770686 ↗
• MalfunctionSep 10, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing on stored episode. 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 50710757 ↗
• MalfunctionSep 10, 2026Pacing Problem; Under-Sensing

  It was reported that that patient experienced lethargy. Upon device assessment it was noted that the Right Ventricular (RV) lead exhibited under sensing, resulting in inappropriate pacing. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Fatigue

  MAUDE report 50710019 ↗
• MalfunctionSep 7, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650967 ↗
• MalfunctionSep 4, 2026High impedance

  It was reported that the Right Ventricular (RV) lead triggered chronic high out of range bipolar impedance warning. 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 50605046 ↗
• MalfunctionSep 3, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing under reporting of Atrial Tachycardia/Atrial Fibrillation (AT/AF) events and inappropriate pacing. It was also reported that the Right Ventricular (RV) lead exhibited undersensing resulting in false termination of episode and inappropriate pacing. 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 50589126 ↗
• MalfunctionSep 2, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564748 ↗
• MalfunctionSep 1, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545864 ↗
• MalfunctionAug 31, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516326 ↗
• MalfunctionAug 28, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds and intermittent undersensing. It was further reported that the Right Ventricular (RV) lead exhibited high thresholds. The RA was reprogrammed and remains in use. 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 50495284 ↗
• MalfunctionAug 28, 2026Under-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 resulting in termination of AT/AF detected event(s) in progress along with Right Ventricular (RV) lead exhibiting undersensing that did not affect the device performance. Low P waves were noted as well. 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 50491027 ↗
• InjuryAug 27, 2026Intermittent Capture; Electrical /Electronic Property Problem; High impedance; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds with intermittent RV capture and high and rising impedance tripping a polarity switch and the patient had a syncopal event. The patient also stated that every night they felt like they were going to pass out around three am. The RV lead was capped and replaced. No further patient complications have been reported asa result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50474678 ↗
• MalfunctionAug 27, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high 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 50474021 ↗
• MalfunctionAug 27, 2026Decreased Sensitivity

  It was reported that the Right Ventricular (RV) lead exhibited a decrease in R-wave amplitude. 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 50470953 ↗
• InjuryAug 27, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high Out of Range (OOR) impedance. 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 50470234 ↗
• MalfunctionAug 25, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead was undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episod es occasionally resulting in termination of AT/AF detected event(s) in progress. It was also reported the Right Ventricular (RV) lead was undersensing 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 50426141 ↗
• MalfunctionAug 25, 2026Pacing Problem; Under-Sensing

  It was reported that the patient experienced dizziness/ near syncope and the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness; Presyncope

  MAUDE report 50425942 ↗
• InjuryAug 24, 2026Intermittent Capture; High Capture Threshold

  It was reported that the patient experienced syncope, a fall and was in a car accident. It was further reported that the Cardiac Res ynchronization Therapy Pacemaker (CRT-P) exhibited a pacing issue, the Right Ventricular (RV) lead exhibited high thresholds and intermittent capture  and that the Left Ventricular (LV) lead exhibited no capture.  The CRTP system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 50409014 ↗
• MalfunctionAug 21, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing noted on stored episodes. 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 50367590 ↗
• MalfunctionAug 21, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50365901 ↗