FINELINE® II Sterox 4479Recalls & reported problems

Summary

The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 00802526061936), received between Jul 8, 2013 and Sep 4, 2026 — classified as 1 death, 208 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (35 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Extracardiac stimulation; Low impedance

  It was reported that this right atrial (RA) lead triggered exhibited low out of range pace impedance measurements. Technical Services (TS) was consulted and found several dips on RA pace impedance measurements with multiple out of range measurements. TS recommended troubleshooting in hopes of reproducing the out of range measurements or any noise. No adverse patient effects were reported. This RA lead remains in service.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50602200 ↗
• MalfunctionAug 14, 2026Device Dislodged or Dislocated

  Patient problems: Burning Sensation

  MAUDE report 50254238 ↗
• InjuryJul 29, 2026Fracture; Material Integrity Problem

  It was reported that this right atrial (RA) lead had fractured and insulation was compromised after physician was making the pocket and accessing the old device with electrical cautery. This lead was surgically abandoned, and a new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065983 ↗
• MalfunctionApr 24, 2026Failure to Capture; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT) TESTS ON THIS RIGHT ATRIAL (RA) LEAD WERE NOTED TO BE SUSPENDED. TECHNICAL SERVICES (TS) WAS CONSULTED, UPON REVIEW OF THE AVAILABLE INFORMATION SUSPECTED LOSS OF CAPTURE (LOC), LOW INTRINSIC AMPLITUDE AND HIGH CAPTURE THRESHOLDS WERE OBSERVED. THIS RIGHT ATRIAL (RA) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE ASSOCIATED PACEMAKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24989682 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24613973 ↗
• InjuryMar 7, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS RA LEAD FRACTURE RESULTED IN THE LEAD SEPARATING IN HALF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539894 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN REASON. A NEW LEAD WAS IMPLANTED NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525086 ↗
• MalfunctionFeb 24, 2026Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING OPTIONS, AS WELL AS RECOMMENDED TO VERIFY THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT) TEST ACCURACY. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428726 ↗
• MalfunctionFeb 6, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED POSSIBLE INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP). IT WAS ALSO NOTED THAT THE PACE IMPEDANCE MEASUREMENTS FOR THE RIGHT ATRIAL (RA) LEAD WAS HIGH OUT OF RANGE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280580 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 23698380 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23468888 ↗
• InjuryOct 30, 2025Failure to Capture; Defective Device; High Capture Threshold; Failure to Capture; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A GRADUAL RISE IN CAPTURE THRESHOLD AND IT WAS SUSPECTED THAT THE LEAD HAD BEEN DAMAGED DURING AN UNRELATED PROCEDURE. THE LEAD WAS SENSING APPROPRIATELY AND HAD WITHING RANGE IMPEDANCES. THE LEAD WAS CONFIRMED TO BE EXHIBITING FAILURE TO CAPTURE. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430129 ↗
• InjuryOct 8, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Defective Device; Signal Artifact/Noise; High impedance; Over-Sensing; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251389 ↗
• InjuryOct 6, 2025Signal Artifact/Noise; Defective Device; Signal Artifact/Noise; Defective Device

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON THIS RA LEAD WAS SURGICALLY ABANDONED WAS NOISE POST TRICUSPID VALVE REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221705 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD EXPERIENCED BURNING AT THE IMPLANT SITE. THE PATIENT WAS REFERRED TO A PHYSICIAN. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD REMAINS IN SERVICE.

  Patient problems: Burning Sensation; Unspecified Infection

  MAUDE report 22787746 ↗
• MalfunctionAug 12, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO EXHIBIT LOSS OF CAPTURE (LOC). THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) INQUIRING IF THE RA LEAD LOC WOULD MAKE THE DEVICE SYSTEM NOT MAGNETIC RESONANCE IMAGING (MRI) CONDITIONAL. TS REVIEWED LABELING AND DISCUSSED WHAT WOULD MAKE A DEVICE SYSTEM NOT MRI CONDITIONAL. IT WAS SUSPECTED THAT THE RA LEAD MAY HAVE DISLODGED. THE MRI SCAN WAS NOT DONE, AT THIS TIME, THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787725 ↗
• MalfunctionJul 14, 2025High impedance; Over-Sensing; Failure to Read Input Signal; Low impedance; High impedance; Over-Sensing; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THE SYSTEM WITH THIS RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED WITHIN RANGE HIGH PACING IMPEDANCE INCREASING GRADUALLY OVER A PERIOD OF THREE MONTHS. ADDITIONALLY, RV LEAD NOTED TO HAVE BOUNCY THRESHOLD READINGS BETWEEN 0.8 VOLTS AND 3 VOLTS. PRESENTING ELECTROCARDIOGRAM SHOWED RA HAD POOR P WAVE MORPHOLOGY AND FARFIELD OVERSENSING. THERE WERE NO CHANGES MADE TO THE LEAD. THIS SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491775 ↗
• MalfunctionJul 8, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS AND NON-PHYSIOLOGIC NOISE. LEAD FRACTURE WAS SUSPECTED; HOWEVER, THIS WAS NOT CONFIRMED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440537 ↗
• InjuryMay 19, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THI RIGHT ATRIAL (RA) LEAD WAS EXHIBITING LOSS OF CAPTURE (LOC). THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044933 ↗
• InjuryMay 7, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE OTHER/NON PRODUCT EXPERIENCE. THE PROCEDURE WAS SUCCESSFULLY PERFORMED AND A NEW LV LEAD WAS IMPLANTED INSTEAD. NOT FURTHER DETAILS WERE PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21978650 ↗
• InjuryApr 24, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PACEMAKER DEVICE THAT WAS IMPLANTED IN HIM SINCE 2003. HE STATED HIS ORIGINAL PACEMAKER AND LEADS OF BOSTON SCIENTIFIC WAS IMPLANTED IN (B)(6) 2003. HE SAID NO ONE TOLD HIM THE LEADS SHOULD BE REPLACED EVERY 5 TO 7 YEARS. UP UNTIL 3 YEARS AGO, HE WAS HAVING THE SAME LEADS AND WAS NOT AWARE THAT THEY SHOULD HAVE BEEN CHANGED A LONG TIME AGO. HE SAID ONE DOCTOR TOLD HIM THEY SHOULD ONLY LAST 5 TO 7 YEARS. HE SAID HE SAW A DOCTOR IN 2022 AND THAT DOCTOR ONLY CHANGED THE PACEMAKER AND THE BATTERY. HE SAID AFTER THE REPLACEMENT HE WAS STILL GETTING INAPPROPRIATE SHOCKS AND INCORRECT TRANSMISSION. HE SAID IN (B)(6) OF 2024 IN ONE DAY, HE GOT 12 INAPPROPRIATE SHOCKS. THEN HE WENT TO ANOTHER DOCTOR WITH HIS CONCERNS AND IN (B)(6) OF 2024, THE ENTIRE SYSTEM HAS BEEN REPLACED. HE SAID WHEN THE DOCTOR WAS CHANGING THE LEADS THEY WERE ROTTEN, DETERIORATED AND CRUMBLED. NOW HE DOES NOT HAVE ANY PROBLEMS WITH THE NEW SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905937 ↗
• MalfunctionMar 3, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED ELEVATED HIGH THRESHOLD BUT NO NOISE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED IF THE DEVICE IS DETECTING, SENSING, AND ATR MODE SWITCHING APPROPRIATELY. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS LEAD EXHIBITED UNDERSENSING. THE HEALTHCARE PROFESSIONAL (HCP) HAS ADJUSTED THE RA SENSITIVITY. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) DISCUSSED POSSIBLE ATRIAL FIBRILLATION (AF) SINCE CONTINUOUS ATRIAL ARRHYTHMIA AND NOISE. ADDITIONALLY, ATR EPISODES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511248 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 21364787 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792904 ↗
• MalfunctionOct 22, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE (LOC). NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511098 ↗