NA 5071-35 (UDI 00643169638594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 327 adverse event reports that list this exact device (DI 00643169638594), received between Dec 9, 2016 and Sep 8, 2026 — classified as 1 death, 204 injuries, 122 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (146 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 327 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia leading to septicemia post generator change. The patient was hospitalized and treated with antibiotics. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system remains in use. The patient is a part icipant in a clinical study. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50671215 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient developed an infection with the device and the leads. The patient was noted to have Methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia and purulent drainage/pus was noted around the CRT-D. It was also noted there was an infected hematoma. The CRT-D, Right Atrial (RA) lead and Right Ventricular (RV) lead were explanted along with a previously capped RV lead. The epicardial Left Ventricular (LV) lead and a redundant epicardial LV lead were cut and pulled down into the chest cavity and remain in the patient. Pocket debridement was performed and a drain was placed. The patient received temporary pacing until a leadless Implantable Pulse Generator (IPG) was later implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Hematoma; Purulent Discharge

  MAUDE report 50350561 ↗
• MalfunctionAug 4, 2026Capturing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133821 ↗
• InjuryJul 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted for an unknown reason. The two Left Ventricular (LV) Epicardial leads were capped for an unknown reason. In addition, two Lead Cap kits were attempted and not used for 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 50099902 ↗
• InjuryJul 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted for an unknown reason. The two Left Ventricular (LV) Epicardial leads were capped for an unknown reason. In addition, two Lead Cap kits were attempted and not used for 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 50099884 ↗
• InjuryJul 1, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS. THE LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676744 ↗
• MalfunctionJun 29, 2026Over-Sensing

  IT WAS REPORTED THAT FIVE DAYS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE ATRIAL AND VENTRICULAR OVERSENSING WAS NOTED ON THE A STORED EPISODE. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 25649529 ↗
• InjuryJun 19, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE. 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 25558050 ↗
• InjuryJun 11, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED AND REPLACED FOR UNKNOWN REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469374 ↗
• MalfunctionJun 8, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE HIGH IMPEDANCE, HIGH THRESHOLDS, AND NOISE. IT WAS ALSO NOTED THAT BOTH LEFT VENTRICULAR (LV) LEADS EXHIBITED OUT OF RANGE LOW IMPEDANCE. THE LV LEADS ARE CONNECTED TOGETHER BY AN ADAPTOR. ALL 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 25424502 ↗
• MalfunctionJun 2, 2026High Capture Threshold

  IT WAS REPORTED APPROXIMATELY THREE WEEKS POST IMPLANT 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 25358511 ↗
• MalfunctionMay 22, 2026Over-Sensing; High Capture Threshold; Unstable Impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE WARNING. THE IPG REMAINS IN USE. IT WAS NOTED THAT TWO EPICARDIAL LEADS WERE CONNECTED TO THE IPG VIA A Y-ADAPTOR. IT WAS REPORTED THAT THE LEADS EXHIBITED HIGH THRESHOLDS, VARIABLE IMPEDANCE AND OVERSENSING. 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 25255482 ↗
• MalfunctionMay 22, 2026Over-Sensing; High Capture Threshold; Unstable Impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE WARNING. THE IPG REMAINS IN USE. IT WAS NOTED THAT TWO EPICARDIAL LEADS WERE CONNECTED TO THE IPG VIA A Y-ADAPTOR. IT WAS REPORTED THAT THE LEADS EXHIBITED HIGH THRESHOLDS, VARIABLE IMPEDANCE AND OVERSENSING. 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 25255443 ↗
• InjuryApr 28, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL RISE IN THRESHOLDS. HIGH THRESHOLDS WERE ALSO OBSERVED. 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 25017923 ↗
• MalfunctionApr 21, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS NOTED THAT NOISE WAS OBSERVED. THE PATIENT HAS TWO EPICARDIAL LEADS WITH A Y ADAPTOR. THE LV 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 24948023 ↗
• MalfunctionApr 21, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS NOTED THAT NOISE WAS OBSERVED. THE PATIENT HAS TWO EPICARDIAL LEADS WITH A Y ADAPTOR. THE LV 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 24948017 ↗
• MalfunctionApr 17, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND CAUSING UNNECESSARY ATRIAL PACING. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. ADDITIONALLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A FALSE OBSERVATION FOR AN INCREASE IN THE LV LEAD THRESHOLD INDICATING THAT THE INCREASE WAS GREATER THAN THE AMPLITUDE SAFETY MARGIN AND MAY HAVE COMPROMISED CAPTURE. THE OBSERVATION DISPLAYED QUESTION MARKS WHERE A NUMERICAL VALUE WOULD TYPICALLY BE DISPLAYED. THE RA LEAD, LV LEAD, AND CRT-D 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 24912510 ↗
• MalfunctionApr 17, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND CAUSING UNNECESSARY ATRIAL PACING. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. ADDITIONALLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A FALSE OBSERVATION FOR AN INCREASE IN THE LV LEAD THRESHOLD INDICATING THAT THE INCREASE WAS GREATER THAN THE AMPLITUDE SAFETY MARGIN AND MAY HAVE COMPROMISED CAPTURE. THE OBSERVATION DISPLAYED QUESTION MARKS WHERE A NUMERICAL VALUE WOULD TYPICALLY BE DISPLAYED. THE RA LEAD, LV LEAD, AND CRT-D 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 24912493 ↗
• MalfunctionApr 14, 2026Pacing Problem

  IT WAS REPORTED THAT THERE WAS "ODD" ELECTROGRAMS (EGM) RECORDED ON THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT IT OCCURRED AFTER EACH RIGHT VENTRICULAR (RV) LEAD PACING EVENT AND ARE NO LONGER PRESENT WHEN RV PACING IS INHIBITED, THE IPG 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 24873145 ↗
• InjuryApr 13, 2026High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, OVERSENSING, AND HIGH 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 24855573 ↗
• MalfunctionApr 9, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEADS CONNECTED TO AN Y ADAPTOR, EXHIBITED CHRONIC LOW OUT OF RANGE UNIPOLAR IMPEDANCE WARNINGS. 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 24826466 ↗
• MalfunctionApr 9, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEADS CONNECTED TO AN Y ADAPTOR, EXHIBITED CHRONIC LOW OUT OF RANGE UNIPOLAR IMPEDANCE WARNINGS. 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 24826454 ↗
• MalfunctionApr 3, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING NOTED ON RECORDED VENTRICULAR FIBRILLATION (VF) AND NON- SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE HIGH THRESHOLDS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ¿MISFIRED.¿ THE RV LEAD, LV LEAD, AND CRT-D 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 24780728 ↗
• InjuryMar 25, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXHIBITED SHORTNESS OF BREATH AND LOSS OF CONSCIOUSNESS WITHOUT A PULSE DURING A NEPHROLOGY APPOINTMENT. UNSURE OF UNDERLYING RHYTHM AT THE TIME OF ARREST, BUT HAD ONE ONE SHOCK AND GOT ROSC AFTER THIS. PATIENT WAS INTUBATED AND TAKEN TO HOSPITAL. DEVICE INTERROGATION SHOWED SEVEN EPISODES OF NON-SUSTAINED VT. PATIENT HAD HEART RATES IN THE HRS IN THIRTIES AND FORTIES AND WAS NOT CAPTURING ON TELEMETRY SO RV PACING OUTPUT WAS REPROGRAMMED TO PROVIDE SAFETY MARGIN AND ENSURE CAPTURE. PATIENT RECEIVED NEW TRANSVENOUS CRTD SYSTEM IMPLANTED. DUE TO PATIENT HEALTH STATUS AND HIGHER INVOLVEMENT IN REMOVING EXISTING ABDOMINAL PACEMAKER, ABDOMINAL AZURE PACEMAKER PROGRAMMED ODO WITH RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS STILL CONNECTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Bradycardia; Cardiac Arrest; Dyspnea; Syncope/Fainting

  MAUDE report 24687030 ↗
• MalfunctionMar 4, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 24504516 ↗