CapSure®Z Novus 5554-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 320 adverse event reports that list this exact device (DI 00681490135047), received between Feb 9, 2017 and Sep 8, 2026 — classified as 1 death, 145 injuries, 174 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (90 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 320 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026High impedance

  It was reported that the patient experienced lethargy. The Right Atrial (RA) lead exhibited high impedance. The Implantable Pulse Generator (IPG) had reached its End of Service (EOS). The RA lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Lethargy

  MAUDE report 50663384 ↗
• MalfunctionAug 26, 2026High Capture Threshold

  It was reported that the patient experienced chest pain. Upon device assessment it was noted that the Right Ventricular (RV) lead exhibited under sensing resulting in inappropriate pacing. It was also reported that the Right Atrial (RA) lead exhibited high thresholds. Both leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain

  MAUDE report 50449556 ↗
• MalfunctionAug 10, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191466 ↗
• MalfunctionJun 19, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING FALSE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTIONS. 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 25561070 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONIC BIPOLAR AND UNIPOLAR LOW OUT OF RANGE IMPEDANCE WARNINGS ALONG WITH NOISE AND OVERSENSING ON STORED EPISODES RESULTING IN FALSE EPISODE DETECTIONS. ATRIAL LEAD POSITION CHECK FAILURE WAS OBSERVED AS WELL. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS. BOTH THE RV AND RA 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 25226778 ↗
• InjuryApr 14, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED PREVIOUSLY FOR AN UNKNOWN REASON. BOTH LEADS WERE 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 24868673 ↗
• MalfunctionApr 7, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. 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 24799331 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED 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 24773684 ↗
• MalfunctionMar 5, 2026Signal Artifact/Noise; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD SUSPECTED FRACTURES AND EXHIBITED NOISE. 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 24518460 ↗
• MalfunctionFeb 24, 2026Electrical /Electronic Property Problem; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDEFINED HIGH IMPEDANCE WITH POLARITY SWITCH. IT ALSO NOTED OVERSENSING AND INAPPROPRIATE MODE SWITCHING .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 24429461 ↗
• MalfunctionFeb 5, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA (AT) / ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 24269203 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER P ATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24243702 ↗
• MalfunctionJan 27, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AND UNNECESSARY PACING 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 24190595 ↗
• InjuryJan 23, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEAD HAD FRACTURED. 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 24159408 ↗
• MalfunctionJan 23, 2026Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. IT WAS FURTHER NOTED THAT THE RA LEAD EXHIBITED UNDERSENSING, RESULTING IN UNNECESSARY PACING. 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 24159144 ↗
• MalfunctionJan 19, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON THE ATRIAL LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS CAUSING INAPPROPRIATE ATRIAL PACING, DEVICE CLASSIFIED FALSE TERMINATION OF AT/AF AND MISCLASSIFICATION OF VENTRICULAR TACHYCARDIA (VT) EPISODES. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FLUCTUATING IMPEDANCE. THE RA AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24108702 ↗
• InjuryNov 27, 2025High impedance; Device Dislodged or Dislocated; High impedance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED HIGH IMPEDANCE. 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 23665511 ↗
• MalfunctionNov 19, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. 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 23597844 ↗
• MalfunctionNov 12, 2025Electrical /Electronic Property Problem; Over-Sensing; Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN INAPPROPRIATE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AND AN 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 23531236 ↗
• MalfunctionOct 17, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO INTERMITTENTLY UNDERSENSE, WHICH WAS SUSPECTED TO HAVE RESULTED IN INAPP ROPRIATE ATRIAL PACING. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR EPISODES DETECTED AS VENTRICULAR FIBRILLATION (VF) AND FAST VENTRICULAR TACHYCARDIA (FVT) THAT WERE POSSIBLY ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). OF NOTE, THE ATRIAL ARRHYTHMIA WAS NOTED DURING THESE EPISODES AND SUSPECTED TO BE ASSOCIATED WITH ATRIAL UNDERSENSING. THE RA LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325389 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; High Capture Threshold; Electrical /Electronic Property Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON CURRENT AND STORED ELECTROGRAMS (EGM) AND SHORT V-V IN TERVALS. THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL LEAD POSITION CHECK FAILURE AND HIGH 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 23299280 ↗
• MalfunctionSep 10, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING AND FALLING IN BLANKING AT TIMES, POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENT(S). 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 23016281 ↗
• MalfunctionAug 29, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) 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 22920824 ↗
• MalfunctionJul 30, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AROUND THE PACER SITE AND PAIN DOWN THE LEFT ARM. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE AND WAS UNABLE TO CONFIRM LEAD FUNCTION. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Pain

  MAUDE report 22662480 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A CARDIAC TRANSPLANTATION. IT WAS NOTED THAT THERE WAS SOME SUSPICION PREOPERATIVELY THAT THE PATIENT HAD LEAD RELATED ENDOCARDITIS. IT WAS REPORTED THAT PORTIONS OF THE RIGHT VENTRICULAR (RV) LEAD AND CORONARY SINUS LEFT VENTRICULAR (LV) LEAD HAD SOME THROMBUS OR VEGETATION ON THEM. THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Medical device site infection

  MAUDE report 22649682 ↗