ATTAIN STARFIX® 419588Recalls & reported problems

Summary

The FDA's MAUDE database contains 316 adverse event reports that list this exact device (DI 00885074511955), received between Oct 10, 2014 and Sep 28, 2026 — classified as 5 deaths, 218 injuries, 93 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (91 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 316 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Capturing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926271 ↗
• MalfunctionSep 16, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793664 ↗
• MalfunctionSep 1, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited Out of Range (OOR) high pacing impedance , oversensing resulting in inhibition of pacing and misclassification of episode type. The lead also exhibited noise.  The patient experienced palpitations and shortness of breath. The lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Dyspnea; Palpitations

  MAUDE report 50550578 ↗
• InjuryAug 20, 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 with sepsis. No further patient complications have been reported as a result of this event.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50357830 ↗
• InjuryJun 25, 2026Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE-OUT, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT-OF-RANGE, UNDEFINED PACING IMPEDANCE, A LOSS OF CAPTURE, AND HAD A FRACTURE. THE LEAD WAS LEFT IMPLANTED, BUT IS NOW OUT-OF-SERVICE AND A NEW LV LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621667 ↗
• MalfunctionJun 12, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. THE LEFT VENTRICULAR (LV) LEAD TRIGGERED ALERTS FOR LOW PACING IMPEDANCE, THE MEASUREMENTS WERE CONSISTENT WITH HISTORICAL VALUES. THE RA AND 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 25488929 ↗
• InjuryMay 27, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NON-CAPTURE. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICAT IONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301296 ↗
• MalfunctionMay 14, 2026Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW 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 25172945 ↗
• InjuryMay 13, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD CHRONICALLY EXHIBITED NO CAPTURE. THE LV LEAD WAS CAPPED, REMAINS IN THE PATIENT OUT OF SERVICE AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164604 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, INFECTION, AND SEPSIS POSSIBLY DUE TO A URINARY TRACT INFECTION APPROXIMATELY FOUR MONTHS PRIOR TO THE EVENT. THE PATIENT EXPERIENCED AN ADDITIONAL URINARY TRACT INFECTION APPROXIMATELY THREE MONTHS PRIOR TO THE EVENT. ADDITIONALLY, VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. DURING THE EXPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE RIGHT VENTRICLE REQUIRING A STERNOTOMY AND REPAIR. DURING THE EXPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE CORONARY SINUS THAT WAS REPAIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Perforation of Vessels; Sepsis; Unspecified Infection

  MAUDE report 24974740 ↗
• InjuryMar 24, 2026Fracture; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOW VOLTAGE FRACTURE WITH A LEFT VENTRICULAR (LV) TIP TO RIGHT VENTRICULAR (RV) COIL LEAD PACING IMPEDANCE WARNING AND UNDEFINED HIGH PACING IMPEDANCE. THE LEAD ALSO EXHIBITED PRIOR SPIKE IN PACING IMPEDANCE AND HIGH THRESHOLD. 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 24677058 ↗
• MalfunctionMar 20, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24653912 ↗
• MalfunctionMar 20, 2026Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR LOW 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 24652258 ↗
• MalfunctionFeb 19, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED OF LOSS OF CAPTURE AND THAT THE PATIENT'S EJECTION FRACTION WAS BEING REDUCED. 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 24394902 ↗
• InjuryFeb 12, 2026High impedance; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED HIGH UNDEFINED PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED AND THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 24319987 ↗
• MalfunctionJan 30, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED OUT OF RANGE (OOR) HIGH DEFIBRILLATION IMPEDANCE AND HIGH RV THRESHOLD. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) LOW PACING 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 24223850 ↗
• DeathNov 5, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS ALLEGED THAT THE ACTIVE FIXATION LOBES OF THE LEAD PROMOTED AGGRESSIVE SCAR TISSUE GROWTH THAT MADE EXTRACTION UNUSUALLY DIFFICULT AND DANGEROUS. THE LV LEAD LOBES OF THE LEAD DID NOT RETRACT AS DESIGNED. THE LOBES ULTIMATELY CAUSED A CORONARY SINUS TEAR RESULTING IN CARDIAC TAMPONADE, WHICH RESULTED IN EMERGENCY SURGICAL REPAIR VIA STERNOTOMY AND CARDIOPULMONARY BYPASS. THE PATIENT SUFFERED OXYGEN DEPRIVATION FOR APPROXIMATE 25-30 MINUTES, RESULTING IN PERMANENT BRAIN DAMAGE, SHORT TERM MEMORY LOSS, PHYSICAL PAIN, AND OTHER SERIOUS INJURIES. THE LV LEAD WAS IMPLANTED FOR APPROXIMATELY TEN YEARS PRIOR TO EXPLANT. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED APPROXIMATELY TWO YEARS PRIOR TO THE PATIENT'S DEATH.

  Patient problems: Brain Injury; Cardiac Tamponade; Hypoxia; Memory Loss/Impairment; Pain; Vascular Dissection

  MAUDE report 23478215 ↗
• MalfunctionOct 27, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF THE THRESHOLD VALUE.  THE CRT-D REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED IMPEDANCE WARNING LVTIP TO RVCOIL FOR HIGH UNDEFINED IMPEDANCE AND POSSIBLE CAPTURE ISSUE NOTED WITH PATIENT EXPERIENCE OF SHORTNESS OF BREATH.  THE LV LEAD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23396971 ↗
• InjuryOct 15, 2025Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE AND POCKET STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS PROGRAMMED OFF UNTIL IT WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23285739 ↗
• InjurySep 15, 2025Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS HIGH UNDEFINED LEFT VENTRICULAR (LV) LEAD PACING 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 23059716 ↗
• MalfunctionSep 10, 2025Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS FURTHER REPORT THAT THE LV LEAD HAD BEEN EXHIBITING OUT OF RANGE (OOR) LOW PACING IMPEDANCE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AT TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016073 ↗
• InjuryJul 16, 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, AND POSSIBLE VEGETATION WAS OBSERVED ON ALL LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A NEW SYSTEM WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22524409 ↗
• InjuryJul 2, 2025Low impedance; Capturing Problem; Low impedance; Capturing Problem

  IT WAS REPORTED THAT A LEAD IMPEDANCE ALERT TRIGGGERED ON THE LEFT VENTRICULAR (LV) LEAD DUE TO LOW PACING IMPEDANCE. THERE WERE RISING LV CAPTURE THRESHOLDS NOTED. IN ADDITION, THERE WERE HIGH CAPTURE THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE WITH A POSITION CHECK FAILURE. REPROGRAMMING WAS PERFORMED FOR THE RV AND LV LEADS. 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 22385474 ↗
• MalfunctionJun 30, 2025Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED FOR UNKNOWN REASONS. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS FRACTURED. THE RIGHT ATRIAL (RA) LEAD, LEFT VENTRICULAR (LV) LEAD AND THE RV LEAD EXHIBITED INCREASING THRESHOLDS AND THE RV AND THE LV IMPEDANCES WERE INCREASING. THE RA AND 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 22366860 ↗
• MalfunctionJun 20, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THERE WAS AN IMPEDANCE WARNING ON THE LEFT VENTRICULAR (LV) 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 22297192 ↗