FINELINE® II Sterox 4458Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00802526060953), received between Apr 25, 2016 and Mar 5, 2026 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED THE PACING IMPEDANCE WAS GREATER THAN 3000 OHMS. ADDITIONALLY, OVERSENSED SIGNALS WERE OBSERVED ON THE RV SENSING CHANNEL PRIOR TO THE LSS EVENT. TS SUSPECTED A LEAD CONDUCTOR ISSUE. EVALUATION OF THE LEAD IN BOTH BIPOLAR AND UNIPOLAR PACING CONFIGURATIONS WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526912 ↗
• InjuryOct 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED INFECTION AND EROSION. A LASER EXTRACTION WAS PERFORMED WITH THIS RV LEAD. FURTHERMORE, THE PHYSICIAN STATED THAT THE LEADS EXTRACTED WERE TERRIBLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WILL NOT BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 20349422 ↗
• InjuryMay 3, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES MEASURING GREATER THAN 2000 OHMS. FURTHER TESTING WAS PERFORMED, AND THE RESULTS APPEARED TO SHOW RV LEAD FRACTURE. IT WAS NOTED THAT THE RV LEAD BRADY THERAPY WAS PROGRAMMED OFF AND DEACTIVATED. AT THIS TIME, THE LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240348 ↗
• InjuryDec 18, 2023Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED FRACTURE, DUE TO THIS, NOISE, OVERSENSING AND HIGH PACING IMPEDANCE ISSUES WERE OBSERVED. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342747 ↗
• InjuryNov 15, 2023High impedance; Device Sensing Problem; No Apparent Adverse Event; High impedance; Device Sensing Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD MALFUNCTION. THIS RV LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137914 ↗
• InjuryApr 13, 2023Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF 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 16737393 ↗
• InjuryNov 17, 2022High impedance; No Apparent Adverse Event; High Capture Threshold; High impedance; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813489 ↗
• InjuryAug 3, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH OUT-OF-RANGE (OOR) RIGHT VENTRICULAR (RV) PACING IMPEDANCES MEASURING GREATER THAN 3000 OHMS. A LEAD SAFETY SWITCH (LSS) WAS ALSO DECLARED WHICH SWITCHED THE PACE/SENSE CONFIGURATION FROM BIPOLAR TO UNIPOLAR. WHEN THE DEVICE WAS IN UNIPOLAR THERE WERE OBSERVATIONS OF NOISE. ADDITIONALLY, THERE WAS A STORED FALSE SIGNAL ARTIFACT (SAM) EPISODE DUE TO ATRIAL DRIVEN RATES. THE HEALTH CARE PROFESSIONAL (HCP) PROGRAMMED THE MINUTE VENTILATION FEATURE TO PASSIVE AND ACCELEROMETER ONLY. AT THIS TIME, THE PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. THE PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271889 ↗
• InjuryJul 4, 2021Signal Artifact/Noise; Failure to Capture; Impedance Problem; Signal Artifact/Noise; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THE LEAD SAFETY SWITCH WAS TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO OUT-OF-RANGE IMPEDANCE, WHICH RESULTED IN NOISE ON THE RV CHANNEL DUE TO THE CHANGE TO UNIPOLAR PROGRAMMING. THE PACEMAKER WAS PROGRAMMED TO DUAL CHAMBER PACING WITHOUT SENSING. THERE WAS LOSS OF CAPTURE AT 2.0 V AND CAPTURE WAS ACHIEVED ONCE A HIGH OUTPUT WAS OBTAINED; HOWEVER, THE PHYSICIAN ELECTED TO IMPLANT A LEADLESS PACEMAKER (NON-BOSTON SCIENTIFIC PRODUCT) RATHER THAN DO AN RV LEAD REVISION. IT IS UNKNOWN IF THE RV LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114236 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD INFECTION. A REVISION WAS PERFORMED AND THE PACEMAKER ALONG WITH THE RV LEAD WERE EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11128137 ↗
• InjuryJan 10, 2020Failure to Capture; High impedance; Device Sensing Problem; Failure to Capture; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE, NOISE, AND HIGH OUT OF RANGE IMPEDANCE THAT SPIKED OVER 2500 OHMS. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO SURGICALLY ABANDON THE LEAD. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576854 ↗
• MalfunctionMar 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WENT TO THE EMERGENCY ROOM DUE TO A HEART RATE OF 32BPM. THE PATIENT ALSO HAD BEEN EXPERIENCING SORENESS AT THE IMPLANT SITE. THE DEVICE WAS NOT INTERROGATED AT THE HOSPITAL AND THE PATIENT WAS SCHEDULED FOR A DEVICE CHECKED THE DAY OF THIS CALL. THE PATIENT STATED HE HAD BEEN TOLD THAT HE HAD A LOOSE WIRE WHICH WILL NEED REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 7350496 ↗
• InjuryJul 10, 2017Failure to Capture; High impedance; Over-Sensing; Ambient Noise Problem; Failure to Capture; High impedance; Over-Sensing; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM EXHIBITED A PACING IMPEDANCE MEASUREMENT GREATER THAN 2500 OHMS ON THE RIGHT VENTRICULAR (RV) CHANNEL WHICH HAD TRIGGERED THE LEAD SAFETY SWITCH (LSS). ADDITIONALLY, CAPTURE ISSUES WERE NOTED AND THERE WERE STORED EPISODES OF NOISE WHICH HAD BEEN OVERSENSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6696666 ↗
• InjuryApr 10, 2017Failure to Capture; High impedance; Failure to Capture; High impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH PACING IMPEDANCES THAT WERE GREATER THAN 2000 OHMS. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. DURING THE REVISION PROCEDURE, THE RV LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER WHICH CONFIRMED THE LEAD WAS THE SOURCE OF THE REPORTED OBSERVATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478254 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS INVOLVED IN A CASE OF INFECTION AND SEPSIS. IT WAS REPORTED THAT VEGETATION WAS FOUND ON THE PATIENT'S MITRAL VALVE, BUT NOT ON THE LEADS. THE ENTIRE SYSTEM WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 6261547 ↗
• InjuryAug 2, 2016Fracture; High impedance; Over-Sensing; Ambient Noise Problem; Fracture; High impedance; Over-Sensing; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD AND ASSOCIATED DEVICE TRIGGERED A LEAD SAFETY SWITCH FOR OUT OF RANGE IMPEDANCES. THE SYSTEM ALSO DISPLAYED NOISE AND OVERSENSING. ISOMETRICS WERE PERFORMED WHERE NOISE WAS ABLE TO BE ELICITED. THE SYSTEM WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5840162 ↗
• InjuryJul 16, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED WITH TISSUE IN THE TINES NOTED. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT DISLODGEMENT WAS CONFIRMED THROUGH X-RAY. THE RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 5800037 ↗
• InjuryJul 14, 2016Fracture; High impedance; Device Sensing Problem; Fracture; High impedance; Device Sensing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND A DROP IN SENSING. CLAVICULAR CRUSH OF THE LEAD WAS SUSPECTED, AND AT THE LEAD REVISION PROCEDURE IT WAS FOUND THAT THE LEAD WAS COMPLETELY FRACTURED. THE LEAD WAS PARTIALLY CAPPED AND ABANDONED AND THE PROXIMAL PORTION WAS RETURNED FOR ANALYSIS. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5795488 ↗
• InjuryMay 1, 2016Break

  MANUFACTURER REPORT ID #2124215-2015-00504 CORRESPONDS TO THE INITIAL ASR REPORT SUBMITTED FOR EXEMPTION #E2011006. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED. BOSTON SCIENTIFIC RECEIVED INFORMATION IN EARLY-JANUARY 2016 FROM A JOURNAL ARTICLE INVOLVING A CASE IN WHICH A FLEXCATH STEERABLE SHEATH, NORMALLY USED IN CRYOBALLOON CATHETER ABLATION FOR ATRIAL FIBRILLATION, WAS USEFUL IN DIRECTING A BIOPTOME TO A RIGHT VENTRICULAR LEAD FRAGMENT AND THUS ALLOWING FOR COMPLETE LEAD EXTRACTION. A (B)(6) YEAR OLD FEMALE WITH HISTORY OF DIABETES, CHRONIC KIDNEY DISEASE, AND SICK SINUS SYNDROME UNDERWENT DUAL-CHAMBER PACEMAKER IMPLANTATION WHICH INCLUDED A BOSTON SCIENTIFIC DEXTRUS MODEL#4135 IN THE RIGHT ATRIUM (RA) AND FINELINE II MODEL#4458 IN THE RIGHT VENTRICLE (RV). IN 2014, THE PATIENT DEVELOPED STAPHYLOCOCCUS EPIDERMIDIS SEPSIS, WAS FOUND TO HAVE A 1.8 CM RA LEAD VEGETATION ON TEE. THE PATIENT WAS REFERRED FOR SYSTEM REMOVAL. THE PULSE GENERATOR WAS EXPLANTED AND THE RA LEAD WAS EASILY EXTRACTED MANUALLY AFTER RETRACTION OF THE ACTIVE FIXATION HELIX

  Patient problems: Sepsis; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 5623164 ↗
• InjuryApr 25, 2016High impedance; Material Integrity Problem; High impedance; Material Integrity Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS TESTED VIA PACING SYSTEM ANALYZER (PSA) WITH CONTINUED OUT OF RANGE MEASUREMENTS OBSERVED. THE LEAD/DEVICE CONNECTION WAS CHECKED WITH NO ANOMALIES NOTED. THERE WAS A CONCERN OF CLAVICULAR CRUSH ON THE LEAD. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5604053 ↗