Capsure®SP Novus 5092-52 (UDI 00681490125048)Recalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 00681490125048), received between Feb 9, 2017 and Sep 23, 2026 — classified as 4 deaths, 180 injuries, 110 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (84 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 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026High impedance; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds and out of range 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 50869117 ↗
• MalfunctionAug 13, 2026Electrical /Electronic Property Problem; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234579 ↗
• MalfunctionJul 7, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED EPISODES RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NOISE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, WITH CURRENT THRESHOLDS REMAINING WITHIN NORMAL LIMITS AND ARE CONSISTENT. THE IPG WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). 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 25734249 ↗
• InjuryJun 5, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE 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 25406111 ↗
• InjuryMay 28, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25318728 ↗
• MalfunctionMay 1, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATHE AND HEART RATES GOING UP TO ONE EIGHTY AND ONE NINETY BEATS PER MINUTE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER PACING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Tachycardia

  MAUDE report 25054451 ↗
• InjuryApr 27, 2026Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT CAPTURE. THE LEAD WAS CAPPED 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 24995546 ↗
• InjuryApr 22, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. THE LEAD WAS REPROGRAMMED AND 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 24956905 ↗
• MalfunctionApr 13, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A DROP IN IMPEDANCE. THE RV LEAD 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 24859153 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24813054 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTER EVENT DETAILS HERE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Fluid Discharge; Sepsis; Unspecified Infection

  MAUDE report 24574096 ↗
• MalfunctionMar 11, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RARE UNDERSENSING ON STORED EPISODES. THE RV LEAD 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 24568287 ↗
• MalfunctionFeb 25, 2026Electrical /Electronic Property Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY INCREASING IMPEDANCE, A LEAD WARNING FOR HIGH IMPEDANCE IN BIPOLAR CONFIGURATION AND A POLARITY SWITCH. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444789 ↗
• InjuryFeb 25, 2026Signal Artifact/Noise; Intermittent Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING AND HAD NOISE. THE LEAD ALSO HAD INTERMITTENT PACING AND IRREGULAR PACING. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 24441588 ↗
• InjuryFeb 25, 2026Unstable Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441027 ↗
• 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 24243699 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 24092646 ↗
• MalfunctionDec 9, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS), OVERSENSING, AND NOISE. THE RA LEAD AND THE RV LEAD 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 23755769 ↗
• MalfunctionNov 24, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INTERMITTENT INAPPROPRIATE PACING. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2025: IT WAS REPORTED THAT REMOTE MONITORING NETWORK TRANSMISSION NOT EXPORTED TO MONITORING INBOX FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631168 ↗
• InjuryOct 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO NOISE. INITIALLY, THE HIGH VOLTAGE PORTION OF THE LEAD REMAINED IN USE HOWEVER THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED. EIGHT AND A HALF YEARS LATER, THE RV LEAD HAD A SUSPECTED FRACTURE. IT WAS FURTHER REPORTED THAT THE PACE/SENSE PORTION OF A PREVIOUSLY IMPLANTED LEAD WAS REACTIVATED AND EIGHT AND A HALF YEARS LATER THE LEAD EXHIBITED NOISE ON ELECTROGRAMS. THE LEADS WERE SUBSEQUENTLY EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369861 ↗
• InjurySep 19, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED FATIGUE AND DISCOMFORT. THE LEADS WERE PROTRUDING INTO THE SKIN. THE RV LEAD EXHIBITED HIGH THRESHOLDS. THE LEADS WERE REPROGRAMMED AND LATER THE LEADS WERE REPOSITIONED AND REMAIN IN USE.

  Patient problems: Discomfort; Fatigue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094366 ↗
• MalfunctionAug 27, 2025Electrical /Electronic Property Problem; High impedance; Electrical /Electronic Property Problem; High impedance

  IT WAS FURTHER REPORTED THAT THE RV LEAD CONTINUED TO EXHIBIT HIGH UNDEFINED IMPEDANCE WITH ANOTHER POLARITY SWITCH.

  Patient problems: Dyspnea

  MAUDE report 22902096 ↗
• InjuryAug 15, 2025Break; Electrical /Electronic Property Problem; Over-Sensing; Low impedance; Impedance Problem; High Capture Threshold; Break; Electrical /Electronic Property Problem; Over-Sensing; Low impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARYING AND OUT OF RANGE (OOR) LOW IMPEDANCES, A POLARITY SWITCH AND A HIGH SENSING INTEGRITY COUNTER (SIC). HIGH THRESHOLDS WERE ALSO NOTED ON THE RV LEAD. IT WAS NOTED THAT THERE MAY BE A POSSIBLE LEAD INSULATION BREACH. THE RV 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 22813914 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED EROSION AND PURULENT DI SCHARGE/ PUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22793202 ↗
• InjuryJul 11, 2025Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NON-FUNCTIONING. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, HIGH THRESHOLDS AND HAD A HIGH NUMBER OF SHORT V-V INTERVALS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22477550 ↗