ATTAIN STARFIX® 419578Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00885074511986), received between Feb 9, 2017 and Dec 12, 2025 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (13 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE LEAD WAS EXPLANTED WITH NO REPLACEMENT. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD FRACTURED. 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 23790756 ↗
• InjuryAug 18, 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 WITH BACTEREMIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. DURING EXPLANT THE LEFT VENTRICULAR (LV) LEAD, IT WAS NOTED TO HAVE TORE ¿A SIGNIFICANT HOLE IN THE CORONARY SINUS". A POSTERIOR EFFUSION WAS SEEN AND PATIENT REQUIRED A STERNOTOMY. IT WAS NOTED THAT THE PATIENT IS RECOVERING AS EXPECTED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Cardiac Perforation

  MAUDE report 22834158 ↗
• InjuryOct 17, 2024Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, OUT OF RANGE (OOR) HIGH RV COIL AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE WARNINGS, IN ADDITION TO SUSPECTED HIGH VOLTAGE RV COIL AND SVC COIL FRACTURES. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OOR HIGH IMPEDANCE AND NO CAPTURE. IT WAS NOTED THAT ALARMS AND DETECTIONS WERE TURNED OFF. THE 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 20471086 ↗
• InjurySep 30, 2024High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED AND VARYING PACING THRESHOLDS AND THE PATIENT WAS FEELING IT. MONITORING WAS DISABLED AND A FIXED OUTPUT WAS SET. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20333819 ↗
• InjuryAug 5, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. 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 19906853 ↗
• InjuryJun 5, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND LASER LEAD EXTRACTION WAS ATTEMPTED. IT WAS NOTED THAT THERE WAS AN APPARENT HOLE OBSERVED IN THE PATIENT'S HEART AND THERE WAS EXTRACTION TAMPONADE. THE LV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 19467148 ↗
• MalfunctionApr 11, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT AN ALERT TRIGGERED FOR LOW PACING IMPEDANCE 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 19089979 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE ENTIRE CRT-D SYSTEM WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947895 ↗
• InjuryMar 3, 2023Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT OF A NEW DEVICE, IT WAS OBSERVED THAT THERE WAS AN INSULATION BREACH ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPAIRED AND THE LEAD WAS TESTED. THE LEAD THRESHOLD AND IMPEDANCE MEASUREMENTS WERE STABLE AND 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 16479291 ↗
• MalfunctionNov 7, 2022Capturing Problem; Capturing Problem

  IT WAS FURTHER REPORTED VIA FOLLOW-UP COMMUNICATION THAT THE POSSIBLE PREMATURE DEPLETION WERE LIKELY DUE TO THE INCREASING RV AND LV THRESHOLDS. THE LV LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15747956 ↗
• InjuryAug 3, 2022Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH AND UNDEFINED IMPEDANCE, NO CAPTURE, AND A POSSIBLE FRACTURE. THE PROXIMAL PORTION OF THE LV LEAD WAS CUT AND CAPPED AND A NEW LV 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 15156986 ↗
• InjuryMay 26, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED LONGEVITY BASED ON PRIOR LONGEVITY ESTIMATES. HIGH OUTPUTS WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD, AND OUTPUTS WERE NOTED TO HAVE BEEN PROGRAMMED UPWARD. THE CRT-D 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 14518455 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 13252247 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING NON-DEVICE RELATED CARDIAC PROCEDURES, THE PATIENT EXPERIENCED PAINFUL, INTERMITTENT, AND VISIBLE PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD THAT DID NOT RESOLVE. THE PHYSICIAN ATTEMPTED TO REPROGRAM THE LV LEAD TO NO AVAIL. THE LV LEAD WAS TURNED OFF AND REMAINS IN THE PATIENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 12791665 ↗
• InjuryJul 15, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED POSSIBLE EARLY BATTERY DEPLETION. THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD WITH NO CAPTURE AT MAXIMUM OUTPUT. THE LV LEAD AND THE DEVICE 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 12172996 ↗
• InjuryAug 10, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387353 ↗
• InjuryMay 7, 2020Adverse 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) SYSTEM WAS EXTRACTED DUE TO A STAPHYLOCOCCUS INFECTION. A SINGLE CHAMBER PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD WERE IMPLANTED AS THE PATIENT IS PACEMAKER DEPENDENT. A NEW CRT-D SYSTEM WAS IMPLANTED ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10033493 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE AND DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 9250840 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. ADDITIONAL INFORMATION REPORTED THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9196687 ↗
• MalfunctionOct 1, 2019Fracture; Fracture

  THE LEFT VENTRICULAR (LV) LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141289 ↗
• InjuryAug 14, 2019Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE AND POSSIBLE PARTIAL FRACTURE ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS INACTIVATED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892936 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY COMPETITOR THAT THE LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8462079 ↗
• InjurySep 6, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. IT WAS SUSPECTED THE RV LEAD HAD FRACTURED. THE RV LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851572 ↗
• InjuryJul 9, 2018Premature Elective Replacement Indicator; Battery Problem; Capturing Problem; High Capture Threshold; Capturing Problem

  IT WAS REPORTED THE LEFT VENTRICULAR (LV) LEAD DISPLAYED INCREASED THRESHOLDS WHICH AFFECTED THE BATTERY LIFE OF THE CARDIAC RESYNCH RONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LV LEAD WAS INACTIVATED HOWEVER THE PATIENT EXPERIENCED DYSPNEA ON EXERTION AND THE LEAD WAS TURNED BACK ON. IT WAS FURTHER REPORTED THERE WAS CHRONIC LEFT DIAPHRAGMATIC STIMULATION. AS THE STIMULATION DID NOT BOTHER THE PATIENT, ONLY THE GENERATOR CHANGE WAS PERFORMED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE LEAD REMAINS IN USE AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Muscle Stimulation

  MAUDE report 7671016 ↗
• InjuryJun 5, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HISTORY OF HIGH THRESHOLDS AND WAS NOT USABLE. THE LV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7571716 ↗