CapSure®Z Novus 5554-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00681490135108), received between Dec 13, 2016 and Sep 24, 2026 — classified as 3 deaths, 108 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (120 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 300 reports, in the reporter's own words as published by the FDA.

• DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator." The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done." The patient expired approximately 8 weeks later.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50883752 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50811348 ↗
• MalfunctionSep 9, 2026Low impedance

  It was reported that the Right Atrial (RA) lead triggered an alert for out of range low pacing 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 50686907 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia. The Implantable Pulse Generator (IPG) system and previously capped Right Ventricular (RV) lead were explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50432541 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a suspected pocket infection. The Implantable Pulse Generator (IPG) system was explante d. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50142970 ↗
• MalfunctionJul 6, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING/NOISE, RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 25714097 ↗
• MalfunctionJun 17, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT NOISE ON THE RIGHT ATRIAL (RA) LEAD WAS OBSERVED. 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 25538232 ↗
• InjuryJun 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) 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 25467516 ↗
• MalfunctionJun 2, 2026Electrical /Electronic Property Problem; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND A ATRIAL LEAD POSITION CHECK FAILURE. 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 25357440 ↗
• MalfunctionMay 28, 2026Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) LOW IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25317388 ↗
• MalfunctionApr 14, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R WAVE OVERSENSING RECORDING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES INCORRECTLY. 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 24872061 ↗
• MalfunctionApr 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 24799320 ↗
• MalfunctionMar 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518918 ↗
• MalfunctionFeb 26, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A RECENT INCREASE IN CAPTURE 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 24454653 ↗
• MalfunctionFeb 17, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI) / NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365131 ↗
• MalfunctionFeb 12, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON CURRENT AND STORED ELECTROGRAMS (EGM) DURING VENTRICULAR TACHYCARDIA (VT) AND ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE AND THE P WAVE IS VERY SMALL BUT STABLE. 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 24320407 ↗
• MalfunctionDec 17, 2025Failure to Capture; Low impedance; Failure to Capture; Low impedance

  IT WAS REPORTED THAT A LEAD WARNING TRIGGERED DUE TO A ZERO IMPEDANCE MEASUREMENT ON THE RIGHT ATRIAL (RA) LEAD. IN ADDITION, THERE WAS A POSSIBLE FAILURE TO CAPTURE. 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 23827267 ↗
• InjuryNov 28, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN EXIT BLOCK AND LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED TO INACTIVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671050 ↗
• MalfunctionNov 17, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. IT APPEARS POTENTIAL ATRIAL UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF AT/AF EVENT(S) 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 23567531 ↗
• MalfunctionNov 7, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDEFINED HIGH IMPEDANCE. IT WAS NOTED THAT THE LEAD IMPEDANCE HAD BEEN HISTORICALLY HIGH. 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 23500625 ↗
• MalfunctionSep 18, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) 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 23083243 ↗
• InjurySep 17, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICAT IONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070550 ↗
• InjurySep 9, 2025Fracture; High Capture Threshold; Fracture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING IMPEDANCES AND HIGH THRESHOLDS. THE RIGHT ATRIAL (RA) LEAD WAS SUSPECTED TO BE FRACTURED AND EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED AND THE RA LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002826 ↗
• MalfunctionAug 20, 2025Low impedance; Low 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 22857266 ↗
• MalfunctionJul 30, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL HIGH RATE EPISODES, TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 22664774 ↗