FINELINE® II Sterox 4456Recalls & reported problems

Summary

The FDA's MAUDE database contains 539 adverse event reports that list this exact device (DI 00802526087752), received between Apr 22, 2016 and Sep 30, 2026 — classified as 5 deaths, 440 injuries, 94 malfunctions.

The most frequently reported specific device problem is “High impedance” (130 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 539 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955154 ↗
• InjurySep 9, 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 adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50685037 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652582 ↗
• MalfunctionAug 24, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421693 ↗
• InjuryAug 20, 2026Device Dislodged or Dislocated

  It was reported that the patient experienced a burning sensation with this right ventricular (RV) lead which was out of place. The Boston Scientific Technical Services consultant referred the patient to the clinic. As of this time, this RV lead remains in service. No adverse patient effects were reported.

  Patient problems: Burning Sensation

  MAUDE report 50335464 ↗
• MalfunctionAug 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291910 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. This RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50018627 ↗
• MalfunctionJun 30, 2026Failure to Capture

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) ON WHAT TECHNICAL SERVICES (TS) SUSPECTED TO BE THE RIGHT VENTRICULAR (RV) CHANNEL. TS NOTED IT WAS NOT CLEAR IF IT WAS THE RIGHT ATRIAL (RA) OR RV CHANNEL, BUT SUSPECTED IT WAS THE RV. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670448 ↗
• MalfunctionJun 9, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR PROGRAMMING ASSISTANCE. THE HCP REPORTED THAT THE PATIENT WITH THIS PACEMAKER SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO SYNCOPE FROM RIGHT VENTRICULAR (RV) LEAD LOSS OF CAPTURE (LOC). TS REVIEWED DEVICE SETTINGS AND PROVIDED PROGRAMMING OPTIMIZATION OPTIONS. THE HCP PERFORMED COMMANDED AUTO THRESHOLD AND REPROGRAMMED THE DEVICE. THE HCP WILL CONTINUE WITH MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Dizziness; Fall; Syncope/Fainting

  MAUDE report 25452062 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO SYSTEMIC INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25379690 ↗
• InjuryMay 28, 2026Fracture; Mechanical Problem; Difficult to Remove; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD UNDERWENT REMOVAL OF A PACEMAKER GENERATOR DUE TO NORMAL BATTERY DEPLETION (NBD) AND EXTRACTION OF A RIGHT VENTRICULAR LEAD THAT WAS DENSELY ADHERENT WITHIN THE SUBCLAVIAN VEIN AND MYOCARDIUM. AFTER INITIAL ATTEMPTS OF RETRACTION FAILED, ALTERNATING USE OF A LASER SHEATH AND A MECHANICAL CUTTING TOOL SUCCESSFULLY FREED THE LEAD FROM MULTIPLE BINDING SITES. THE LEAD WAS FRACTURED. FLUOROSCOPIC VISUALIZATION OF THE RV WAS PERFORMED. THE LEAD WAS ULTIMATELY SEPARATED FROM THE MYOCARDIUM AND WITHDRAWN WITHOUT COMPLICATION. A NEW DUAL CHAMBER PACEMAKER WAS THEN IMPLANTED, THE POCKET WAS REVISED AND CLOSED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25318055 ↗
• InjuryMay 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT ANOMALY. THE LEAD WAS REPLACED SUCCESSFULLY. THIS RV LEAD WILL NOT BE RETURNED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089085 ↗
• MalfunctionApr 17, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PATIENT WITH A RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A SYNCOPAL EPISODE. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL. THERE WAS ALSO NOISE ON THE RV CHANNEL WHICH TS SUSPECTED TO BE MYOPOTENTIALS. TS ALSO NOTED THAT DURING THE RECORDED OVERSENSING THERE WERE CLEAR INTRINSIC BEATS VISIBLE AND AS SUCH NO PACING INHIBITION. TS FURTHER NOTED THERE WAS NO OBVIOUS DEVICE CAUSE OF THE SYNCOPAL EPISODE. TS RECOMMENDED A FULL LEAD EVALUATION AND SUGGESTED REPROGRAMMING OPTIONS. THIS RV LEAD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 24911336 ↗
• 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 24614114 ↗
• MalfunctionMar 10, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RV LEAD EXHIBITING HIGH THRESHOLDS AND AN INCREASE IN PACE IMPEDANCE MEASUREMENTS THAT REMAINED WITHIN RANGE. THE CONFIGURATION WAS SWITCHED TO UNIPOLAR AND THRESHOLD AND IMPEDANCES RETURNED TO PREVIOUS LEVELS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD EXHIBITED A PACE IMPEDANCE MEASUREMENT THAT WENT HIGH OUT OF RANGE RESULTING IN A LEAD SAFETY SWITCH (LSS). THERE IS NO EVIDENCE OF RV LEAD NOISE AT THIS TIME. THIS PATIENT IS ONLY ONE PERCENT RV PACED SO TECHNICAL SERVICES (TS) DISCUSSED IT IS UP TO THE CLINIC FOR THE NEXT STEPS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557894 ↗
• MalfunctionFeb 4, 2026Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CRUSHED DURING THE TRICUSPID VALVE REPAIR. NO EXACT KNOWN OF THE EXTENT OF THE DAMAGED. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THE BEHAVIOR OF THE COMPROMISED RV LEAD WHICH COULD PRESENT WITH BIVENTRICULAR. AS OF THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257077 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT FELL AND LANDED ON THE INCISION. THE INCISION OPENED AND CAUSED AN INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24201840 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. ANOTHER LEAD WAS SUCCESSFULLY PLACED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD. AT THIS TIME, NO FURTHER INFORMATION WAS AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE IN THE FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192282 ↗
• InjuryJan 21, 2026Fracture; High impedance; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE, GREATER THAN 2000 OHMS. IT WAS SUSPECTED THAT THIS RV LEAD WAS FRACTURED, HOWEVER, THIS WAS NOT CONFIRMED. THIS LEAD WAS SCHEDULED TO BE EXPLANTED. DURING THE LASER LEAD EXTRACTION PROCEDURE, THE RIGHT ATRIAL (RA) LEAD BECAME DISLODGED. ALSO, THE TERMINAL TIPS OF BOTH LEADS WERE SEPARATED FROM THE LEAD BODIES. THE TIPS WERE REMOVED FROM THE PATIENT USING A SNARE. THIS RV LEAD AND RA LEAD WERE EXPLANTED. DUE TO THE EXTENDED PROCEDURE, NO NEW LEADS WERE IMPLANTED AT THIS TIME. THIS RV LEAD WAS DISPOSED OF BY THE PHYSICIAN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135316 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24075025 ↗
• InjuryJan 7, 2026High Capture Threshold

  IT WAS REPORTED THAT THE THRESHOLD OF THIS RIGHT VENTRICULAR (RV) LEAD INCREASED FROM 3.05 VOLTS PER 0.5 MILLISECONDS TO 7.5 VOLTS PER 1 SECOND IN A SPAN OF 6 MONTHS SINCE IMPLANT. SUBSEQUENTLY, THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A DIFFERENT LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992708 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23960775 ↗
• InjuryJan 5, 2026Adverse 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. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23960768 ↗
• MalfunctionDec 18, 2025High impedance; Material Integrity Problem; High impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE >3000 OHMS MAYBE DUE TO LEAD MECHANICAL IMPAIRMENT ISSUE AND THE PACING THERAPY COULD BE COMPROMISED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839687 ↗
• InjuryNov 25, 2025Signal Artifact/Noise; High impedance; Insufficient Device Problem Information; High Capture Threshold; Signal Artifact/Noise; High impedance; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. SUBSEQUENTLY, IT WAS REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647043 ↗