FINELINE® II Sterox 4480Recalls & reported problems

Summary

The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 00802526061974), received between Apr 22, 2016 and Sep 30, 2026 — classified as 1 death, 240 injuries, 83 malfunctions.

The most frequently reported specific device problem is “High impedance” (69 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 324 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954575 ↗
• InjurySep 17, 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. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50807703 ↗
• MalfunctionApr 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD WAS SENT TO THE EMERGENCY ROOM (ER) DUE TO STROKE AND WAS CONFIRMED THROUGH X-RAY THAT THE RA LEAD WAS DISLODGED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851160 ↗
• InjuryMar 30, 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 24716101 ↗
• InjuryMar 18, 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. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24626702 ↗
• InjuryMar 8, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY REVISED DUE TO LEAD FOUND TO HAVE MOVED DURING POST OPERATION CHECKED VIA CHEST X RAY. IN ADDITION, THIS RA LEAD EXHIBITED NON CAPTURE AT 5 VOLTS. THIS RA LEAD REMAINS IN SERVICE WITH GOOD NUMBERS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542078 ↗
• InjuryJan 21, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OVER 3000 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) DECIDED TO SURGICALLY ABANDON THIS LEAD AND IMPLANTED A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136759 ↗
• MalfunctionOct 24, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED LEAD LONGEVITY AND REFERRED THE PATIENT TO THE FOLLOWING PHYSICIAN AND TO THE MANUFACTURER OF THE NON BOSTON SCIENTIFIC PACEMAKER FOR FURTHER QUESTIONS. AS OF THIS TIME, THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380854 ↗
• InjuryOct 15, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. ANOTHER LEAD WAS USED TO SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302432 ↗
• InjuryOct 8, 2025Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. ANOTHER LEAD WAS USED TO SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251387 ↗
• InjurySep 16, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONSULTED FOR PROGRAMMING ASSISTANCE DUE TO RIGHT ATRIAL (RA) LEAD NON-CAPTURE AT 5V. IT WAS NOTED THAT THE PATIENT HAD ATRIAL FIBRILLATION (AF) AND DID NOT PACE MUCH IN THE RIGHT VENTRICLE. VDI WAS DISCUSSED, AND TS EXPLAINED THAT VDI WAS ESSENTIALLY VVIR WITH RA SENSING ON. THIS PACEMAKER SYSTEM WAS PROGRAMMED TO DDI WITH LOW OUTPUT ATRIAL SETTINGS. THIS RA LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066802 ↗
• InjuryJul 15, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PACEMAKER SYSTEM WITH THIS RIGHT ATRIAL (RA) LEAD EXHIBITED MANY INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. TECHNICAL SERVICES (TS) ADVISED INAPPROPRIATE ATR EPISODES WERE STORED DUE TO OVERSENSING OF NOISE. IN ADDITION, TS PROVIDED THERE HAD BEEN AN ALERT OF RA OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED PACING IMPEDANCE MEASUREMENTS WERE BOTH HIGH AND LOW OUT OF RANGE. TS SUGGESTED TROUBLESHOOTING OPTIONS. THE PATIENT HAS BEEN SCHEDULED FOR A REVISION PROCEDURE. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509988 ↗
• InjuryJul 11, 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 A POCKET EROSION AND INFECTION. REPORTEDLY, THE PATIENT WAS OFFERED TO BE TRANSFERRED TO TECHNICAL SERVICES TO EXPRESS THE CONCERNS FURTHER BUT DECLINED. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 22476835 ↗
• MalfunctionJul 9, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI) NOISE. TECHNICAL SERVICES (TS) RECOMMENDED THE PATIENT BE BROUGHT INTO CLINIC TO DETERMINE SOURCE OF THE EMI AND TO RE-ENABLE MV. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464409 ↗
• InjuryJun 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO BREAKAGE OR FRACTURE. THERE WAS NO LEAD REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284197 ↗
• InjuryJun 13, 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 POCKET INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22207657 ↗
• InjuryMay 27, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE HIGH PACING THRESHOLD. A NEW RA LEAD WITH A DIFFERENT MODEL WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093293 ↗
• InjuryMay 8, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987190 ↗
• InjuryApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. 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 21939324 ↗
• InjuryMar 26, 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. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE RA LEAD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 21695829 ↗
• InjuryMar 24, 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21683933 ↗
• InjuryFeb 24, 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 RA LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 21449615 ↗
• InjuryJan 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE AND WAS SUBSEQUENTLY SURGICALLY ABANDONED. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277010 ↗
• InjuryJan 9, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS HAVING A HIGH CAPTURE THRESHOLD. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 21110625 ↗
• InjuryDec 30, 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 PART OF THE SYSTEM REVISION DUE TO INFECTION AND ENDOCARDITIS. REPORTEDLY, THE FIELD REPRESENTATIVE INQUIRED ABOUT THE LEAD FEATURES AND DESIGN. THE FIELD REPRESENTATIVE INFORMED THAT THE LEADS WILL BE REMOVED ON A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD REMAINS IN SERVICE.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 21044950 ↗