CapSureFix Novus MRI™ SureScan® 5076-52 (UDI 00643169448896)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,051 adverse event reports that list this exact device (DI 00643169448896), received between Feb 9, 2016 and Sep 28, 2026 — classified as 16 deaths, 896 injuries, 1,139 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (737 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 2,051 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. Low P waves were noted. It was further reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. 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 50911598 ↗
• MalfunctionSep 24, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888808 ↗
• MalfunctionSep 24, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in inappropriate pacing. It was also reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. 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 50882494 ↗
• InjurySep 23, 2026Under-Sensing

  It was reported that both the Right Atrial (RA) and Right Ventricular (RV) lead exhibited undersensing. Both lead sensitivity and polarity were reprogramed 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 50869367 ↗
• InjurySep 17, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited 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 50798452 ↗
• MalfunctionSep 16, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing and failed position check. It was further reported that the Right Ventricular (RV) lead exhibited high thresholds. The leads remained in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784439 ↗
• InjurySep 16, 2026Fracture

  It was reported that the Right Atrial (RA) lead exhibited a fracture. The RA 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 50783686 ↗
• MalfunctionSep 15, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing triggering episode misclassification at times. The RA lead remains in use. It was also reported that the Right Ventricular (RV) lead exhibited intermittent T-wave oversensing. 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 50768320 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50740536 ↗
• MalfunctionSep 2, 2026Failure to Capture; High impedance; High Capture Threshold

  It was further reported that the patient experienced first degree Atrioventricular Block and symptomatic bradycardia with near syncope symptoms which included dizziness, lightheadedness, fatigue and chest heaviness. The RV lead was programmed "off" and remains in the patient.

  Patient problems: Bradycardia; Chest Pain; Dizziness; Fatigue; Heart Block; No Clinical Signs, Symptoms or Conditions; Presyncope

  MAUDE report 50559158 ↗
• MalfunctionAug 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 Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events in progress and 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 50509798 ↗
• InjuryAug 27, 2026Electrical /Electronic Property Problem; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited a failed atrial lead position check (ALPC) and exhibited high thresholds. The lead was programmed off until it was later 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 50470247 ↗
• InjuryAug 26, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  It was reported that the patient experienced a fall and possible stroke. Stored episodes showed Right Atrial (RA) lead undersensing, resulting in inappropriate atrial pacing. Additionally, there was a previous atrial lead position check failure. The RA lead remains in use. No further patient complications have been reported as a result of this event

  Patient problems: Fall; Stroke/CVA

  MAUDE report 50455082 ↗
• MalfunctionAug 25, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442174 ↗
• MalfunctionAug 24, 2026Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds and rising 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 50404157 ↗
• MalfunctionAug 24, 2026Under-Sensing; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds and undersensing during Atrial Tachycardia/Atrial Fibrilla tion (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) 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 50402066 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296938 ↗
• MalfunctionAug 14, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251307 ↗
• MalfunctionAug 13, 2026Electrical /Electronic Property Problem; Over-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232026 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately two weeks post Implantable Pulse Generator (IPG) replacement the patient experienced a pocket infection, pocket erosion, purulent discharge, and bacteremia. The IPG system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Medical device site infection; Pocket Erosion; Purulent Discharge

  MAUDE report 50155837 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection, pocket erosion, and redness. The pacing leads were already capped and replaced. These 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: Erythema; Medical Device Site Inflammation; Pocket Erosion

  MAUDE report 50053927 ↗
• MalfunctionJul 28, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF)  resulting in unnecessary pacing at times. It was noted the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. 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 50053222 ↗
• MalfunctionJul 27, 2026Signal Artifact/Noise; Under-Sensing

  It was further reported that the RA lead was reprogrammed. Noise was then noted with isometrics but was not inhibiting pacing so no further changes were made.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045873 ↗
• InjuryJul 13, 2026Break

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR UNDEFINED HIGH PACING AND DEFIBRILLATION IMPEDANCE. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT WAS SYMPTOMATIC WITH RV PACING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A HIGH VOLTAGE RV LEAD FRACTURE WAS SUSPECTED. THE PATIENT DID RECEIVE AN INAPPROPRIATE SHOCK DUE TO THE FRACTURED RV COIL. IN ADDITION, THE PATIENT EXPERIENCED PAIN AND A BURNING SENSATION IN THEIR CHEST. DURING THE REVISION PROCEDURE, THE RA LEAD WAS NICKED AND BECAME DAMAGED DURING THE RV LEAD EXTRACTION. BOTH THE RV AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25797018 ↗
• MalfunctionJul 13, 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, ALSO RESULTING IN UNNECESSARY 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 25792304 ↗