Capsure®Z Novus 5054-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 273 adverse event reports that list this exact device (DI 00681490123228), received between Apr 10, 2013 and Sep 17, 2026 — classified as 2 deaths, 181 injuries, 90 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (91 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 273 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50811208 ↗
• InjuryAug 27, 2026Defibrillation/Stimulation Problem; Under-Sensing

  It was reported that the patient experienced shortness of breath and the Right Ventricular (RV) lead exhibited undersensing resulting in delay of an episode and early termination. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dyspnea

  MAUDE report 50478809 ↗
• InjuryJul 6, 2026High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DIAGNOSTIC RESET. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. THE IPG 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 25716329 ↗
• MalfunctionJun 9, 2026Electrical /Electronic Property Problem; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH, HIGH UNDEFINED IMPEDANCE AND HIGH THRESHOLDS. A GRADUAL RISE IN IMPEDANCE WAS NOTED. LEAD MINERALIZATION WAS SUSPECTED. 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 25443888 ↗
• MalfunctionMay 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC 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 25121413 ↗
• InjuryApr 23, 2026Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRE-SYNCOPE. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope

  MAUDE report 24962766 ↗
• MalfunctionMar 30, 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 24726363 ↗
• MalfunctionMar 11, 2026Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN IMPEDANCE. IT WAS FURTHER NOTED THAT THE RV LEAD EXHIBITED AN INCREASE IN 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 24569393 ↗
• MalfunctionMar 9, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS ON STORED EPISODES. 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 24543572 ↗
• InjuryJan 22, 2026High Capture Threshold

  IT WAS FURTHER REPORTED THAT PACEMAKER MEDIATED TACHYCARDIA WAS SUSPECTED. IT WAS FURTHER NOTED THAT THE RA AND RV LEAD WAS REPROGRA MMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 24146390 ↗
• InjuryJan 13, 2026Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING IMPEDANCE AND RISING THRESHOLDS. 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 24050952 ↗
• MalfunctionNov 17, 2025Pacing Problem; Under-Sensing; Decreased Sensitivity; Pacing Problem; Under-Sensing; Decreased Sensitivity

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED LOW AMPLITUDE R-WAVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568553 ↗
• MalfunctionNov 11, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS AS WELL AS OVERSENSING ON THE VENTRICULAR 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 23522293 ↗
• MalfunctionNov 7, 2025Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASING R WAVES. 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 23496214 ↗
• MalfunctionNov 3, 2025Break; Break

  THE PATIENT REPORTED THAT THEY WERE SHORT OF BREATH ALL THE TIME AND THAT ONE OF THEIR PACING LEADS WAS BROKEN. THE PACING LEAD REMAINS IN USE. ;NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 23449353 ↗
• InjuryOct 16, 2025Signal Artifact/Noise; Fracture; High impedance; High Capture Threshold; Unstable Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED FRACTURE, HIGH IMPEDANCE, HIGH THRESHOLD, UNSTABLE THRESHOLD AND NOISE. 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 23310800 ↗
• MalfunctionOct 15, 2025Over-Sensing; Over-Sensing

  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 23298586 ↗
• InjurySep 15, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. HIGH IMPEDANCE, NOISE AND OVERSENSING WERE ALSO OBSERVED. THE LEAD WAS REPROGRAMMED AND LATER CAPPED WITH REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058663 ↗
• MalfunctionJul 18, 2025Failure to Capture; Over-Sensing; Capturing Problem; Unstable Capture Threshold; Failure to Capture; Over-Sensing; Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT NON-CAPTURE, VARIABLE THRESHOLDS AND LARGE INCREASES IN THRESHOLDS. A HIGH SENSING INTEGRITY COUNTER (SIC) WAS ALSO OBSERVED. IT WAS NOTED "PATIENT HAD BEEN SYMPTOMATIC". THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22540041 ↗
• MalfunctionJun 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE, NO SENSING AND LOW IMPEDANCE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO SENSING ALSO. 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 22307751 ↗
• MalfunctionJun 5, 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 A RISE IN IMPEDANCE AND HIGH OUT OF RANGE IMPEDANCE RESULTING POLARITY SWITCH. 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 22148848 ↗
• InjuryJun 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT A LEAD ¿NEEDS TO BE REPLACED AND IT WAS TURNED OFF AT SOME POINT.¿ IT WAS SUBSEQUENTLY NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO 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 22133436 ↗
• InjuryMay 26, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD NOISE. THE LEADS WERE 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 22084378 ↗
• MalfunctionFeb 19, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO 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 21408497 ↗
• InjuryFeb 10, 2025Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT APPROXIMATELY FIVE AND A HALF YEARS POST RIGHT VENTRICULAR (RV) LEAD IMPLANTATION, THE LEAD FRACTURED AND WAS REPLACED WITH ANOTHER RV LEAD. IT WAS FURTHER REPORTED THAT APPROXIMATELY FIFTEEN YEARS LATER, THE REPLACEMENT RV LEAD HAD A SUSPECTED FRACTURE IN THE VOLTAGE PORTION AND EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE AND HIGH THRESHOLDS. THE TWO LEADS WERE PARTIALLY CLIPPED AND CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344139 ↗