FINELINE® II Sterox 4457Recalls & reported problems

Summary

The FDA's MAUDE database contains 726 adverse event reports that list this exact device (DI 00802526060915), received between Apr 1, 2014 and Sep 17, 2026 — classified as 5 deaths, 599 injuries, 122 malfunctions.

The most frequently reported specific device problem is “High impedance” (171 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 726 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50807661 ↗
• InjurySep 7, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652223 ↗
• InjuryAug 14, 2026Pacing Problem; Use of Device Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced system shortness of breath (SOB) and fatigue. It was noted there was suspicious pacing behavior observed on the electrograms (EGMs). It was hypothesized that at the time of the device upgrade in 2023, the old right ventricular (RV) lead was placed incorrectly in the right atrial (RA) port of this CRT-D, and the old RA lead was mistakenly surgically abandoned. The physician performed a pocket exploration and confirmed the old RV lead was attached to the atrial port, and the RA lead was abandoned. The RV lead was removed from the atrial port and replaced with the RA lead. It was also noted the patient would continue to be monitored and that the patient had an increase in ejection fraction since the CRT-D was implanted. This RV lead was surgically abandoned. No additional adverse patient effects were reported.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 50260520 ↗
• InjuryAug 11, 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 was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50209684 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PREVIOUSLY CAPPED RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED INFECTION POSSIBLE POCKET EROSION. THE PATIENT REPORTED THAT THE DEVICE APPEARED TO BE PROTRUDING FURTHER FROM THE POCKET FOLLOWING WEIGHT LOSS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PREVIOUSLY CAPPED RV LEAD REMAINED CAPPED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 25728155 ↗
• MalfunctionJun 12, 2026Over-Sensing; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED POCKET STIMULATION. THE DEVICE EXPERIENCED MINUTE VENTILATION SIGNAL OVERSENSING. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25493752 ↗
• InjuryJun 3, 2026Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) ON TELEMETRY WITHOUT PAUSES OR SYNCOPE. ADDITIONAL INFORMATION INDICATES THAT THERE WAS NO LOSS OF CAPTURE OR BRADYCARDIA. FURTHERMORE, MICRO-DISLODGEMENT WAS CONFIRMED BY CHEST X RAY FOLLOWING LEFT ARM MOVEMENT ONE HOUR POST-OPERATION, RESULTING IN ELEVATED PACING THRESHOLDS. THIS RV LEAD WAS THEN EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385243 ↗
• InjuryMay 13, 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 25164138 ↗
• InjuryMay 6, 2026Fracture

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PARTIALLY SURGICALLY ABANDONED AND EXPLANTED DUE TO LEAD FRACTURE WHICH WAS DISCOVERED DURING GENERATOR CHANGE. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104843 ↗
• InjuryMay 5, 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 25076773 ↗
• MalfunctionMay 4, 2026High impedance

  IT WAS REPORTED THAT, DURING EVALUATION PRIOR TO A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE, THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS SLIGHTLY ABOVE 2000 OHMS. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND CONFIRMED THAT THE IMPEDANCE VALUES HAVE REMAINED STABLE AROUND THIS VALUE SINCE APPROXIMATELY THREE YEARS PRIOR. BASED ON THE AVAILABLE DATA, DEVICE FUNCTION APPEARS STABLE; HOWEVER, THE DECISION TO PROCEED WITH THE MRI REMAINS CLINICAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071269 ↗
• InjuryApr 22, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24958076 ↗
• InjuryApr 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 24874575 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24807823 ↗
• InjuryApr 2, 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 POSSIBLE INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 24769099 ↗
• MalfunctionMar 20, 2026Signal Artifact/Noise; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO AN ABRUPT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT IN THE BIPOLAR CONFIGURATION, MEASURING GREATER THAN 3000 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO RECREATE THE OUT OF RANGE MEASUREMENT IN BIPOLAR; HOWEVER, IT WAS NOTED THAT UNIPOLAR PACING IMPEDANCE MEASURED AT ABOUT 2200 OHMS. MINIMAL NOISE WAS OBSERVED IN BIPOLAR, AND LOSS OF CAPTURE (LOC) WAS EXHIBITED IN UNIPOLAR AND BIPOLAR. THE HCP IMPLEMENTED PROGRAMMING CHANGES THAT TECHNICAL SERVICES (TS) RECOMMENDED. PRIOR TO THE LSS, IT WAS NOTED THAT THE PATIENT EXPERIENCED A FALL. SUBSEQUENTLY, TS SUSPECTED THERE WAS A LEAD FRACTURE AND RECOMMENDED PERFORMING A CHEST X-RAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652016 ↗
• InjuryMar 18, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24626708 ↗
• MalfunctionMar 17, 2026Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS IN THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONTACTED AND NOTED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE (LOC). THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624283 ↗
• InjuryFeb 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370061 ↗
• MalfunctionFeb 11, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD AN UNKNOWN ISSUE. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312775 ↗
• MalfunctionFeb 5, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THE PACEMAKER SYSTEM INCLUDING THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED FOR A MAGNETIC RESONANCE IMAGING (MRI). THE HEALTH CARE PROFESSIONAL REPORTED THE PRESENTING ELECTROGRAM EXHIBITED RV LOSS OF CAPTURE (LOC). A THRESHOLD TEST WAS COMPLETED WHICH ALSO SHOWED RV LOC. THE PATIENT WAS NOT SYMPTOMATIC AND NO PAUSES IN PACING WERE EXHIBITED. THE MRI WAS NOT COMPLETED, AND THE PATIENT WAS TO BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268992 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND POCKET REDNESS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD REMAINS IMPLANTED.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 24031939 ↗
• InjuryJan 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED DUE TO UNKNOWN CAUSE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967667 ↗
• 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 23956207 ↗
• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND THE LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. BOTH PRODUCTS WERE SUCESFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805229 ↗