Capsure®Z Novus 5054-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 309 adverse event reports that list this exact device (DI 00681490123167), received between Feb 9, 2017 and Sep 14, 2026 — classified as 6 deaths, 189 injuries, 114 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (105 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 309 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The RV lead remains in use. 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. 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 50751018 ↗
• InjurySep 3, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Impedance Problem

  It was reported that the patient experienced syncope and Right Ventricular (RV) lead exhibited loss of capture, non-physiologic inte rvals, and noise. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50583205 ↗
• MalfunctionJul 10, 2026Break; Over-Sensing; Unstable Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779207 ↗
• MalfunctionJun 23, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, OVERSENSING AND OVERSENSING RESULTING IN MISCLASSIFICATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. 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 25595133 ↗
• MalfunctionJun 18, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING . 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 25543006 ↗
• MalfunctionMay 20, 2026High Capture Threshold

  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 25226772 ↗
• MalfunctionApr 29, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THERE WAS A HIGH V-V COUNT ON THE SENSING INTEGRITY COUNTER (SIC), NOISE 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 25031865 ↗
• 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 24773676 ↗
• MalfunctionMar 31, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS. 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 24740072 ↗
• MalfunctionMar 20, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LETHARGY. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND FALSE TERMINATION OF EPISODE. ADDITIONALLY,  RIGHT VENTRICULAR (RV) LEAD DISPLAYED UNDER SENSING RESULTING IN INAPPROPRIATE PACING INTO VENTRICULAR TACHYCARDIA (VT) EPISODE OR T-WAVE. BOTH THE LEADS REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Lethargy

  MAUDE report 24647580 ↗
• MalfunctionMar 18, 2026Impedance Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN IMPEDANCE AND VARIABLE THRESHOLDS. THE RA AND RV LEADS BOTH 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 24634708 ↗
• 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 24518466 ↗
• MalfunctionJan 29, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED SLIGHT VARIABILITY IN LEAD TREND PARAMETERS, IT WAS NOTED THERE WERE "QUES TIONABLE" ATRIAL INTERVALS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WITH SUSPECTED LEAD 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 24214916 ↗
• MalfunctionJan 28, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTED IN UNDER PACING ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-CAPTURE. 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 24197200 ↗
• MalfunctionJan 19, 2026Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE R IGHT ATRIAL (RA) LEAD EXHIBITED AN OUT OF RANGE (OOR) LOW IMPEDANCE WARNING AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 24108564 ↗
• MalfunctionJan 12, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT 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 24034128 ↗
• InjuryNov 21, 2025Intermittent Capture; Unstable Capture Threshold; Intermittent Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSTABLE THRESHOLDS WITH INTERMITTENT CAPTURE. 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 23615823 ↗
• InjuryNov 4, 2025Over-Sensing; Low impedance; Device Sensing Problem; Unstable Capture Threshold; Over-Sensing; Low impedance; Device Sensing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND UNSTABLE THRESHOLDS. THE LEAD WAS EXPLANTED AND REP LACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463148 ↗
• InjuryAug 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS CAUSING EARLY BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE RV LEAD WAS CAPPED AND REPLACED. THE IPG 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 22770818 ↗
• MalfunctionJul 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) 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 22517803 ↗
• InjuryJul 11, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDEFINED HIGH IMPEDANCE AND THE LEAD WAS NOTED TO BE FRACTURED. 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 22478896 ↗
• InjuryJul 8, 2025Pacing Problem; Extracardiac stimulation; Impedance Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Pacing Problem; Extracardiac stimulation; Impedance Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THERE WAS NO PERFORMANCE ISSUE WITH THE IPG. THE RV LEAD OUTPUTS WERE REPROGRAMMED. IT WAS ALSO NOTED THAT THE IMPEDANCE HAD STABILIZED.

  Patient problems: Device Overstimulation of Tissue; Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434446 ↗
• InjuryJul 4, 2025Break; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem; High Capture Threshold; Break; Failure to Capture; Electrical /Electronic Property Problem; Fracture; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT BECAME SYMPTOMATIC WITH LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED FRACTURE, HIGH IMPEDANCE, POLARITY SWITCH, RISING IMPEDANCE, AND HIGH THRESHOLDS. IT WAS NOTED THAT THE LEAD EXHIBITED INSULATION BREACH AT THE LEAD TIP OR SEVERE ENCAPSULATION/MINERALIZATION OF THE LEAD TIP. THE LEAD WAS REPROGRAMMED AND LATER EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22403400 ↗
• MalfunctionJun 18, 2025Electrical /Electronic Property Problem; High impedance; Impedance Problem; Electrical /Electronic Property Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH BIPOLAR AND UNIPOLAR IMPEDANCE AND A POLARITY SWITCH. 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 22271237 ↗
• InjuryJun 13, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD HAD VARYING IMPEDANCE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22201138 ↗