NA 5071-53 (UDI 00681490124454)Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 00681490124454), received between Feb 9, 2016 and Sep 11, 2026 — classified as 1 death, 206 injuries, 105 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (132 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 312 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740661 ↗
• InjuryAug 25, 2026Capturing Problem; High Capture Threshold

  It was reported that the epicardial Right Ventricular (RV) lead exhibited rising and high thresholds resulting in the ventricular pacing output increasing to 5.0 Volts at 1.0 milliseconds, increasing pacing output, resulting in increased battery utilization and contributed to the Implantable Pulse Generator (IPG) reaching Recommended Replacement Time (RRT) sooner than previously estimated. The IPG was explanted. The RV lead was capped and remains in the patient. A leadless IPG was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430886 ↗
• MalfunctionMay 27, 2026Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS NOTED THAT PACER SPIKES WERE NOT PICKING UP ON THE MONITOR AND THAT THE PATIENT'S HEART RATE WAS NOTED TO BE IN THE 40S-80S WHICH IS LOWER THE PROGRAMMED LOWER RATE SETTING. IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY. THE CRT-P REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHANGES IN IMPEDANCE THAT WERE FALLING. 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 25302799 ↗
• MalfunctionMay 27, 2026Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS NOTED THAT PACER SPIKES WERE NOT PICKING UP ON THE MONITOR AND THAT THE PATIENT'S HEART RATE WAS NOTED TO BE IN THE 40S-80S WHICH IS LOWER THE THE PROGRAMMED LOWER RATE SETTING. THE CRT-P REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHANGES IN IMPEDANCE THAT WERE FALLING. 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 25302707 ↗
• MalfunctionMay 1, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED ALERTS FOR OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE AND WAS SUSPECTED TO HAVE HIGH VOLTAGE COIL FRACTURE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED FOR THE RV LEAD. THE LEADS 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 25062313 ↗
• MalfunctionApr 28, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED 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 25017780 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION AND PATIENT DICOMFORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 25016346 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690244 ↗
• InjuryFeb 3, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A SUSPECTED FRACTURE AND HIGH OUT OF RANGE IMPEDANCE. 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 24245517 ↗
• InjuryJan 6, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23974184 ↗
• InjuryDec 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A "MECHANICAL BREAKDOWN OF CARDIAC ELE". THE LEFT VENTRICULAR (LV) LEAD, RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825576 ↗
• InjuryDec 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A "MECHANICAL BREAKDOWN OF CARDIAC ELE". THE LEFT VENTRICULAR (LV) LEAD, RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825554 ↗
• InjuryDec 10, 2025Intermittent Capture; Fracture; High impedance; Over-Sensing; Device Sensing Problem; Intermittent Capture; Fracture; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. ADDITIONALLY, IT WAS REPORTED THAT THE RV LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE, OVERSENSING, NOISE, AND A SMALL DECREASE IN TIP-TO-COIL IMPEDANCE MEASUREMENTS OVERTIME. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NICKED DURING A PRIOR PROCEDURE AND REPAIRED WITH A CHEMICAL ADHESIVE AT THAT TIME. ADDITIONALLY, IT WAS REPORTED THAT THE LV LEAD IS PLUGGED INTO THE R LEAD PORT AND IS FRACTURED. THE RV LEAD IS PLUGGED INTO THE LV LEAD PORT AND IS FRACTURED. THE RIGHT ATRIAL (RA) LEAD IS FRACTURED AND EXHIBITED HIGH, UNDEFINED IMPEDANCE. THE RA LEAD ALSO DID NOT HAVE RELIABLE SENSING AND EXHIBITED INTERMITTENT CAPTURE. IT WAS ALSO NOTED THAT THE RA LEAD EXHIBITED CROSSTALK AND WAS REPROGRAMMED. NO FURTHER INTERVENTION WAS TAKEN AS THE PATIENT IS AWAITING TRANSPLANT. THE RA LEAD, RV LEAD AND LV 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 23769630 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT VENTRICULAR (RV) LEAD, AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED, AND THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO BACTEREMIA AND FEVER. THE ORGANISM WAS IDENTIFIED AS VANC OMYCIN-RESISTANT ENTEROCOCCI (VRE). A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Fever

  MAUDE report 23512853 ↗
• InjuryOct 30, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE AND A FRACTURE WAS SUSPECTED. THE LV LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424433 ↗
• MalfunctionSep 17, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD POSSIBLY DISPLAYED A LOSS OF 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 23076878 ↗
• InjuryAug 22, 2025Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT A FRACTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO REPORTED THAT THE LV LEAD EXHIBITED HIGH LV PACING IMPEDANCE AND HIGH LV THRESHOLDS. THE LV 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 22877829 ↗
• InjuryAug 18, 2025Unstable Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED UNSTABLE THRESHOLDS. THE LV 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 22827284 ↗
• MalfunctionAug 14, 2025High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE LV IMPEDANCE CONTINUED TO RISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805306 ↗
• InjuryAug 4, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. THE CRT-D WAS EXPLANTED AND REPLACED, AND THE LV LEAD WAS CAPPED AND REPLACED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ALL LV LEADS EXHIBITED HIGH CAPTURE THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. IT WAS NOTED THAT A LV LEAD BECAME DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709404 ↗
• InjuryAug 1, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685946 ↗
• InjuryJul 17, 2025Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED SUSPECTED FRACTURE, HIGH IMPEDANCE AND NO 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 22535698 ↗
• InjuryJul 10, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. THE CRT-D WAS EXPLANTED AND REPLACED, AND THE LV 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 22474033 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 22310464 ↗
• MalfunctionMay 23, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW 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 22077035 ↗