CapSureFix Novus MRI™ SureScan® 5076-58 (UDI 00643169448902)Recalls & reported problems

Summary

The FDA's MAUDE database contains 698 adverse event reports that list this exact device (DI 00643169448902), received between Dec 9, 2016 and Sep 23, 2026 — classified as 6 deaths, 430 injuries, 262 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (172 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 698 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Capture

  It was reported that the patient experienced Ventricular Tachycardia (VT) and there was a loss of capture in the Right Ventricular (RV) lead. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50868714 ↗
• MalfunctionSep 6, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50638150 ↗
• MalfunctionAug 20, 2026Pacing Problem; Under-Sensing

  It was reported that the patient experienced weakness and high blood pressure. The Right Atrial (RA) lead exhibited an abrupt increase in capture threshold measurements and inability to confirm consistent capture on the current electrograms (EGM). It was also noted that the Right Ventricular (RV) lead exhibited undersensing on current electrograms (EGM) and stored episodes resulting in inappro priate pacing. Both leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: High Blood Pressure/ Hypertension; Muscle Weakness/Atrophy

  MAUDE report 50344884 ↗
• MalfunctionAug 13, 2026Over-Sensing; Low impedance; High Capture Threshold

  It was reported that there was high thresholds , low impedance and oversensing on the Right Ventricular (RV) lead. 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 50232497 ↗
• MalfunctionJul 28, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058435 ↗
• 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 50053907 ↗
• MalfunctionJul 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25745763 ↗
• MalfunctionJul 2, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25688033 ↗
• MalfunctionJun 26, 2026Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ALONG WITH HIGH 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 25639664 ↗
• MalfunctionJun 25, 2026Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING AND HIGH THRESHOLDS. 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 25617903 ↗
• InjuryJun 3, 2026Break; Over-Sensing; Low impedance; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE INSULATION BREACH WITH LOW/FALLING IMPEDANCE, RISING THRESHOLDS AND OVERSENSING. 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 25374376 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AND THE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. THE RV LEAD WAS INACTIVATED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 25373358 ↗
• MalfunctionMay 27, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH 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 25299566 ↗
• MalfunctionMay 21, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED BOTH HIGH AND LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH 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 25239094 ↗
• MalfunctionMay 20, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE ON CURRENT ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NON-FUNCTIONAL. BOTH 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 25226745 ↗
• MalfunctionMay 19, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVER SENSING, INSULATION BREACH AND FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS ALSO REPORTED THAT BOTH RA AND RIGHT VENTRICULAR (RV) LEADS DISPLAYED NOISE. 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 25217432 ↗
• InjuryMay 14, 2026Break; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD A VISIBLE INSULATION BREACH. THE LEAD WAS REPAIRED WITH MEDICAL ADHESIVE AND A SUTURE SLEEVED WAS PLACED OVER THE AREA TO REINFORCE AND SECURE THE REPAIR. 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 25173162 ↗
• MalfunctionMay 11, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED INCREASING 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 25136625 ↗
• InjuryMay 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090768 ↗
• MalfunctionMay 4, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS LIKELY FRACTURED. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED HIGH OUT OF RANGE (OOR) UNDEFINED IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. 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 25071727 ↗
• MalfunctionApr 29, 2026Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WITH POSSIBLE INAPPROPRIATE PACING AND AFFECTING MODE SWITCH. THE RA LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT UNDERSENSING WAS NOTED ON CURRENT ELECTROGRAMS (EGM) WITH VENTRICULAR SENSING WITH SAFETY PACE. THE RA LEAD FUNCTION WAS UNABLE TO BE CONFIRMED AND THE LEAD POSITION CHECK FAILED WITH POSSIBLE LOSS OF CAPTURE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING WITH LOSS OF CAPTURE ON CURRENT EGM. 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 25026247 ↗
• MalfunctionApr 28, 2026Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND SLOWLY RISING IMPEDANCE OVER THE PREVIOUS TWO WEEKS. 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 25013769 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EXPERIENCED PURULENT DISCHARGE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITH NO REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24977192 ↗
• InjuryApr 20, 2026High impedance; Capturing Problem; Impedance Problem; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A PERFORMANCE ISSUE. THE LEAD WAS CAPPED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923799 ↗
• MalfunctionApr 17, 2026Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND DIMINISHED SENSING. 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 24908051 ↗