Capsure®SP Novus 5092-58 (UDI 00681490125109)Recalls & reported problems

Summary

The FDA's MAUDE database contains 350 adverse event reports that list this exact device (DI 00681490125109), received between Dec 9, 2016 and Sep 23, 2026 — classified as 3 deaths, 226 injuries, 121 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (103 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 350 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under and over sensing resulting in inappropriate pacing. It was also reported that the RA lead exhibited intermittent undersensing noted on stored episodes which resulted in false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. Low P waves were also observed Both 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 50865909 ↗
• InjurySep 8, 2026Failure to Capture

  It was reported that the patient experienced syncope. Upon device assessment it was noted that the Right Ventricular (RV) lead exhibited loss of capture. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50663379 ↗
• 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 50142973 ↗
• MalfunctionMay 13, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE WITH NOISE NOTED ON BOTH PACING LEADS. IT WAS ALSO NOTED THAT THE NOISE WAS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD AND THE LEAD EXHIBITED A POSITION CHECK FAILURE. THE IPG SYSTEM 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 25158691 ↗
• InjuryMay 5, 2026High Capture Threshold

  IT WAS NOTED THAT THE RV LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25077331 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25015895 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEADS WERE EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO A BLOOD BORNE INFECTION WITH ADDITIONAL PATIENT SYMPTOMS OF SEPSIS/SEPTICEMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24978029 ↗
• MalfunctionApr 23, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ARRHYTHMIA, SMALL P WAVES AND NOT CAPTURING DURING PRESENTING ELECTROGRAMS (EGM) STRIP DUE TO ATRIAL ARRHYTHMIA. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RARE FUNCTIONAL UNDERSENSING AND OVERSENSING DURING ATRIAL THERAPY WITH SHORT V-V INTERVALS. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 24964746 ↗
• InjuryFeb 10, 2026Low impedance; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE LOW IMPEDANCE AND UNSTABLE 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 24302797 ↗
• MalfunctionFeb 4, 2026High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVER SENSING, NOISE, FAR FIELD R-WAVE (FFRW) OVERSENSING AND HIGH THRESHOLDS. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH THRESHOLDS. BOTH THE LEADS REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24258105 ↗
• MalfunctionFeb 4, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING. 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 24257640 ↗
• MalfunctionJan 28, 2026Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VENTRICLE HIGH-RATE (VHR) EPISODES THAT LIKELY WERE SHOWING SOME NON-PHYSIOLOGIC INTERVALS. THERE WAS ALSO A NOTED INCREASE IN 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 24197793 ↗
• DeathJan 19, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT'S REPRESENTATIVE MENTIONED THAT THE "PATIENT FLATLINED AND ASKED IF MEDTRONIC SAW ANYTHING". ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24107263 ↗
• MalfunctionDec 22, 2025Failure to Capture; Decreased Sensitivity; Unstable Capture Threshold; Failure to Capture; Decreased Sensitivity; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE, UNSTABLE THRESHOLDS AND VARIABLE 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 23864005 ↗
• InjuryDec 9, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS INACTIVATED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757972 ↗
• MalfunctionNov 25, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED A HIGH NUMBER OF SHORT V-V INTERVALS. 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 23645045 ↗
• InjuryNov 20, 2025Failure to Capture; Capturing Problem; High Capture Threshold; Failure to Capture; Capturing Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RV LEAD LOSS OF CAPTURE WAS DUE TO HIGH THRESHOLDS.

  Patient problems: Bradycardia

  MAUDE report 23602691 ↗
• MalfunctionNov 19, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. 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 23591865 ↗
• MalfunctionOct 31, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM). 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 23435097 ↗
• MalfunctionOct 22, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH NUMBER OF SHORT V-V INTERVALS. THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING THAT WAS DISPLAYED ON VENTRICULAR ELECTROGRAMS (EGM). 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 23356336 ↗
• InjuryOct 21, 2025Over-Sensing; Pacing Problem; Impedance Problem; Over-Sensing; Pacing Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR RISING IMPEDANCE AND EXHIBITED OVERSENSING ON STORED EGMS RESULTING IN INAPPROPRIATE PACING. THE RA LEAD REMAINS IN USE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23347982 ↗
• InjuryOct 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACEMENT WITH A LEADLESS PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278423 ↗
• MalfunctionSep 15, 2025Intermittent Capture; Electrical /Electronic Property Problem; High impedance; High Capture Threshold; Intermittent Capture; Electrical /Electronic Property Problem; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE ALONG WITH A 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 23053671 ↗
• MalfunctionAug 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. 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 22837219 ↗
• MalfunctionAug 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT THEY HAVE A "BAD LEAD". 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 22791383 ↗