NA 5071-35 (UDI 00681490124379)Recalls & reported problems

Summary

The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 00681490124379), received between Dec 9, 2016 and Aug 25, 2026 — classified as 3 deaths, 214 injuries, 105 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (168 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Low impedance

  It was reported that the Left Ventricular (LV) lead exhibited low impedance. The LV 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 50426786 ↗
• MalfunctionJul 1, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED UNDEFINED HIGH OUT OF RANGE (OOR) PACING 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 25680870 ↗
• MalfunctionJun 10, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE ELECTROGRAMS (EGM) WAS NOT COMPLETE AND RAILING OFFLINE ON RIGHT VENTRICULAR (RV) LEAD SIGNAL. THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS. THE RV CAPTURE COULD NOT BE CONFIRMED. THE LEADS AND THE IPG 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 25456754 ↗
• MalfunctionJun 10, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE ELECTROGRAMS (EGM) WAS NOT COMPLETE AND RAILING OFFLINE ON RIGHT VENTRICULAR (RV) LEAD SIGNAL. THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS. THE RV CAPTURE COULD NOT BE CONFIRMED. THE LEADS AND THE IPG 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 25456686 ↗
• InjuryMay 20, 2026Failure to Capture

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS. THE LEAD REMAINS IN USE. IT WAS ALSO NOTED THAT THE PREVIOUS RV LEAD WAS CAPPED DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228511 ↗
• MalfunctionApr 20, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED BUT STABLE THRESHOLDS. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED REDUCED DEVICE LONGEVITY OF LESS THAN FOUR YEARS DUE TO THE CHRONIC, ELEVATED BUT STABLE LEAD THRESHOLDS. THE CRT-P WAS EXPLANTED AND REPLACED, AND 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 24928667 ↗
• InjuryMar 4, 2026Over-Sensing; Capturing Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT A FRACTURE HAD NOT BEEN IDENTIFIED ON EITHER LEAD. IT WAS NOTED THAT THE RV LEAD HAS SHOWN AN INCREASE IN THRESHOLD SINCE IMPLANT, WHICH WAS CAUSING PREMATURE BATTERY DRAIN ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE CRT-P WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512858 ↗
• InjuryMar 3, 2026Fracture; High Capture Threshold

  (B)(6) 2026: IT WAS FURTHER REPORTED THAT NO PERFORMANCE ISSUES WERE NOTED AGAINST THE LV LEAD. THE LV LEAD REMAINS IN USE. THE RV SHOWED OVERSENSING. THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494239 ↗
• MalfunctionFeb 16, 2026Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND WAS NOT PACING. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NO 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 24342579 ↗
• InjuryFeb 12, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH THRESHOLDS. BOTH LEADS WERE CAPPED AND REPLACED DURING A CORONARY ARTERY BYPASS GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322475 ↗
• MalfunctionJan 7, 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 23990036 ↗
• MalfunctionDec 22, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW UNIPOLAR IMPEDANCE WARNINGS. THE RV LEAD AND THE RA 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 23863671 ↗
• MalfunctionDec 3, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF THE THRESHOLD VALUE FOR AN OBSERVATION RELATED TO THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED AND CURRENT ELECTROGRAMS (EGM), TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENTS AT TIMES. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE CRTD AND 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 23706705 ↗
• InjuryNov 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, UNDEFINED IMPEDANCE. THE LEAD WAS PROGRAMMED OFF. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657958 ↗
• MalfunctionNov 13, 2025Electrical /Electronic Property Problem; High impedance; Impedance Problem; Electrical /Electronic Property Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD LEADS, WHICH ARE CONNECTED BY AN ADAPTOR TO MAKE ONE RV LEAD, EXHIBITED A LEAD WARNING FOR POLARITY SWITCH AND AN IMPEDANCE SPIKE TO HIGH UNDEFINED IMPEDANCE. 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 23540533 ↗
• MalfunctionNov 13, 2025Electrical /Electronic Property Problem; High impedance; Impedance Problem; Electrical /Electronic Property Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD LEADS, WHICH ARE CONNECTED BY AN ADAPTOR TO MAKE ONE RV LEAD, EXHIBITED A LEAD WARNING FOR POLARITY SWITCH AND AN IMPEDANCE SPIKE TO HIGH UNDEFINED IMPEDANCE. 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 23540532 ↗
• InjuryNov 11, 2025Failure to Capture; Low impedance; High Capture Threshold; Failure to Capture; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE AND THRESHOLD ABOVE THE PROGRAMMED OUTPUT ON THE LEFT VENTRICULAR (LV) LEAD. A CHECK PRIOR TO A ROUTINE GENERATOR REPLACEMENT SHOWED NO CAPTURE ON THE LV LEAD. INCREASING THE OUTPUT ALLOWED FOR CAPTURE, HOWEVER, IT INTRODUCED PHRENIC NERVE STIMULATION. 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 23522594 ↗
• InjuryNov 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN RE PORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462705 ↗
• InjuryOct 15, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS NOTED ONLY ONE OF THE EPICARDIAL LV LEADS WAS NOTED AT LAST DEVICE CHECK. IT WAS UNKNOWN IF THERE WAS ISSUES WITH THE OTHER LV LEAD. PATIENT WAS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI) AND A REPLACEMENT SYSTEM WAS ADDED WITH LV LEAD REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298980 ↗
• InjuryOct 15, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS NOTED ONLY ONE OF THE EPICARDIAL LV LEADS WAS NOTED AT LAST DEVICE CHECK. IT WAS UNKNOWN IF THERE WAS ISSUES WITH THE OTHER LV LEAD. PATIENT WAS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI) AND A REPLACEMENT SYSTEM WAS ADDED WITH LV LEAD REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298865 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE THE LAST DEVICE CHANGEOUT, THE PATIENT HAD EXPERIENCED CARDIAC STIMULATION WITH LEFT VENTRICULAR (LV) PACING. REPROGRAMMING WAS PERFORMED TO RESOLVE THE STIMULATION ISSUE. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF BEING CHRONICALLY TIRED AND HAVING SHORTNESS OF BREATH. A REVIEW OF THE DEVICE DATA BY QUALIFIED PERSONNEL DETERMINED THAT THERE WAS LEAD POLARIZATION OCCURRING WHICH WAS COMPROMISING THE DEVICE'S EFFECTIVECRT FEATURE. THE LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23076443 ↗
• MalfunctionSep 16, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. 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 23061254 ↗
• InjurySep 4, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT ONE DAY POST GENERATOR CHANGE OUT THE RIGHT VENTRICULAR (RV) LEAD AND THE LEFT VENTRICULAR (LV) LEAD WERE NOT I NSERTED IN THE CONNECTOR CONFIRMED ON X-RAY. THE IMPLANTABLE PULSE GENERATOR (IPG), LV LEAD AND 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 22962278 ↗
• InjurySep 4, 2025High impedance; Low impedance; Connection Problem; High impedance; Low impedance; Connection Problem

  IT WAS REPORTED THAT ONE DAY POST GENERATOR CHANGE OUT THE RIGHT VENTRICULAR (RV) LEAD AND THE LEFT VENTRICULAR (LV) LEAD WERE NOT I NSERTED IN THE CONNECTOR CONFIRMED ON X-RAY. THE IMPLANTABLE PULSE GENERATOR (IPG), LV LEAD AND 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 22962267 ↗
• InjuryJul 25, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT BOTH RIGHT VENTRICULAR (RV) LEADS EXHIBTED HIGH THRSHOLDS. 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 22607454 ↗