FINELINE® II EZ Sterox 4474Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00802526265037), received between Oct 12, 2016 and Apr 6, 2026 — classified as 39 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High impedance” (16 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ON THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CHANNELS DUE TO PACING IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792349 ↗
• InjuryMar 30, 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. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD VEGETATION IN THE LEFT VENTRICULAR GROWING ON THE MITRAL LEAFLETS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24715350 ↗
• InjuryOct 22, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PHYSICIAN PROVIDED THIS RV LEAD WAS FRACTURED. DURING ISOMETRIC TESTING NOISE WAS OVERSENSED AND RESULTED IN PACING INHIBITION. SUBSEQUENTLY, THIS RV LEAD WAS SURGICALLY ABANDONED. ANOTHER LEAD WAS PLACED IN THE RV TO COMPLETE THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23357287 ↗
• InjuryOct 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23197027 ↗
• InjuryMar 13, 2025Signal Artifact/Noise; Defective Device; Signal Artifact/Noise; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO NOISY SIGNALS WHEN THE PATIENT PERFORMED CERTAIN MOVEMENTS. A REPLACEMENT PROCEDURE WAS PERFORMED, WHERE THIS RV LEAD WAS CAPPED, AND A NEW IMPLANTABLE LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596201 ↗
• InjuryDec 31, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO IMPEDANCE ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED HIGH OUT-OF-RANGE BIPOLAR PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS AND STORED EPISODES CONTAINING NOISE. FLUROSCOPIC IMAGING SHOWED NO EVIDENCE OF LEAD DAMAGE. PACING SYSTEM ANALYZER (PSA) TESTING WAS INCONCLUSIVE. VENOGRAM REVEALED LEFT-SIDED SUBCLAVIAN VESSEL OCCLUSION. AS A RESULT, THE PHYSICIAN CHOSE TO ABANDON THE LEFT SIDED DEVIE, AND IMPLANT A NEW SYSTEM ON THE RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21050400 ↗
• MalfunctionJun 26, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE EXHIBITED SIGNAL ARTIFACT MONITOR (SAM) COUPLE OF TIMES AND THERE WAS MINUTE VENTILATION (MV) OVERSENSING AND PACING INHIBITION. THERE WAS NOISE ON THIS RIGHT VENTRICULAR (RV) LEAD. THIS RV LEAD CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613951 ↗
• InjuryMar 21, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS THAT RESULTED IN A LEAD SAFETY SWITCH. A REVISION PROCEDURE WAS PERFORMED DUE TO A SUSPECTED LEAD FRACTURE AND THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956039 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 18423741 ↗
• InjuryNov 20, 2023Signal Artifact/Noise; High Capture Threshold; Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND HIGH PACING THRESHOLD MEASUREMENTS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SUSPECTED CAUSE OF HIGH THRESHOLD WAS DUE TO PATIENT CONDITION. SUBSEQUENTLY, THIS LEAD WAS ABANDONED SURGICALLY, AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168025 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16407923 ↗
• InjuryJan 29, 2023Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY EXPLANTED DUE TO EXHIBITING HIGH, OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3,000 OHMS), SAFETY SWITCH TO UNIPOLAR PACING, AND RISING THRESHOLDS. PRIOR TO BEING EXPLANTED, AN IN-OFFICE X-RAY IMAGE, REVEALED THE VISUAL APPEARANCE OF THE RA LEAD TO BE INTACT. THE RA LEAD WAS SUCCESSFULLY REMOVED, AND A NEW RA LEAD WAS IMPLANTED. THE RA LEAD WAS DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261758 ↗
• InjuryJan 20, 2023Pacing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Pacing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED, CAUSING PACING TO BE COMPROMISED. SUBSEQUENTLY, THE PATIENT WAS IMMEDIATELY HOSPITALIZED, AND SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD IS EXPECTED FOR RETURN. ADDITIONAL INFORMATION: A GOOD FAITH EFFORT WAS SUBMITTED TO THE FIELD TO OBTAIN MORE DETAILED INFORMATION REGARDING WHAT TYPE OF PACING ISSUES WERE A RESULT OF THE DISLODGMENT. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216460 ↗
• InjuryOct 24, 2022High impedance; Pacing Problem; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS. THERE WAS NO NOISE OBSERVED DURING ISOMETRIC TESTING. THE LEAD SAFETY SWITCH (LSS) WAS TRIGGERED, AND THE SETTING WAS CHANGED TO UNIPOLAR. IT WAS ALSO NOTED THAT THE PACING RATE HAD BEEN GRADUALLY INCREASING OF A TIME PERIOD OF SIX MONTHS. A PACEMAKER SYSTEM CHANGEOUT HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657566 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 15514505 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 POCKET INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15498448 ↗
• InjuryJul 5, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD AN INFECTION. A REVISION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED WHILE THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE CAPPED. IN ADDITION, THE TIP OF THE LEADS WERE RETAINED IN THE HEART FOLLOWING THE PROCEDURE. THE PHYSICIAN FRACTURED THE LEADS IN AN ATTEMPT TO EXTRACT THEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 14913779 ↗
• InjuryJun 27, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE INSULATION OF THIS RIGHT VENTRICULAR (RV) LEAD PEELED OFF WITH ADHESIONS EXPOSING THE OUTER CONDUCTOR WHEN DOING A GENERATOR CHANGE. THE POCKET WAS HIGHLY CALCIFIED. THE LEAD WAS SURGICALLY ABANDONED AND WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14827510 ↗
• InjuryJun 2, 2022Signal Artifact/Noise; Pacing Problem; Failure to Sense; Signal Artifact/Noise; Pacing Problem; Failure to Sense

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO SENSING ISSUES AND PACING NOT DELIVERED WHEN REQUIRED CAUSED BY INTERMITTENT NOISE. THE PATIENT WAS REPORTED TO BE EXHIBITING ANXIETY DUE TO THIS LEAD ISSUE. ANOTHER RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anxiety

  MAUDE report 14582725 ↗
• InjuryApr 13, 2022Failure to Capture; Over-Sensing; Data Problem; Failure to Capture; Over-Sensing; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A FALL. LOSS OF CAPTURE (LOC) FOR AN UNKNOWN DURATION WAS OBSERVED ON THIS RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS REPORTED TO BE 62 PERCENT VENTRICULAR PACED AND WAS NOTED TO BE IN ATRIAL FIBRILLATION (AF) WITH THE DEVICE PROGRAMMED VVI AS A RESULT. AN ATTEMPT WAS MADE TO ASSESS THE PRESENTING RHYTHM, HOWEVER, REVIEW OF THE PRESENTING ELECTROGRAM (EGM) SHOWED THE ATRIAL SIGNALS OVER THE VENTRICULAR CHANNEL. THE PHYSICIAN NOTED THAT AN X-RAY WAS PERFORMED AND WOULD BE REVIEWED TO ASSESS LEAD PLACEMENT. ADDITIONAL INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE NOTED THAT THE PATIENT WAS FOUND TO BE IN AF WITH RATES IN THE 70-80 BEATS PER MINUTE (BPM) RANGE. NO ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE ROOT CAUSE OF THE LOC OR OUTCOME OF THE X-RAY. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL AND HAS NOT BEEN IN CONTACT WITH THEIR FOLLOWING PHYSICIAN SINCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107838 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED RIGHT VENTRICULAR (RV) LEAD EXHIBITED INFECTION AND WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14107096 ↗
• MalfunctionApr 6, 2022Signal Artifact/Noise; High impedance; Over-Sensing; Failure to Read Input Signal; Signal Artifact/Noise; High impedance; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT EPISODE REVIEW IDENTIFIED STORED EVENTS WHICH WERE DUE TO RANDOM NOISE THAT RESEMBLED A NON-PHYSIOLOGIC, MECHANICAL SIGNAL ON THE RIGHT VENTRICULAR (RV) CHANNEL. ADDITIONALLY, THE AMOUNT OF EPISODES HAS SIGNIFICANTLY INCREASED OVER THE PAST TWO MONTHS. FURTHER DETAILS REVEALED THAT MINUTE VENTILATION WAS DISABLED DUE TO SIGNAL ARTIFACT MONITOR (SAM). TWO SAM EVENTS WERE NOTED AND NOISE WAS SEEN ON BOTH THE ATRIAL AND RV ELECTROCARDIOGRAMS (EGM) SIMULTANEOUSLY. THE CALLER CONFIRMED THE PATIENT WAS HAVING AN ELECTROPHYSIOLOGY STUDY AT THE TIME OF THE EVENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONCLUDED THE FIRST SAM EVENT WAS A FALSE POSITIVE DUE TO EXTERNAL SOURCE FOLLOWED BY A FAILED SENSOR LEAD CHECK DUE TO OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RV LEAD. THE CONSULTANT DOCUMENTED AND DISCUSSED THE CLINICAL OBSERVATIONS AND PROGRAMMING OPTIONS WERE PROVIDED TO THE CALLER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14033365 ↗
• InjuryMay 5, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781510 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse 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 11767243 ↗
• InjuryApr 13, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. APPROXIMATELY TWO WEEKS LATER, THIS PACEMAKER AND THE RIGHT ATRIAL (RA) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE LEAD CRUSH AS THE LEADS TRIGGERED THE LSS ONE AFTER THE OTHER. NOISE WITH OVERSENSING WAS OBSERVED ON BOTH LEAD CHANNELS, AND SOME OF THIS NOISE APPEARED TO BE UNIPOLAR OVERSENSING. THE NOISE WITH OVERSENSING ON THE RV CHANNEL ALSO APPEARS TO HAVE CORRELATED WITH A PAUSE OF APPROXIMATELY SEVEN SECONDS. MINUTE VENTILATION (MV) SENSOR OVERSENSING WAS NOTED ON THE RV CHANNEL, AS WELL. THE PATIENT ALSO EXPERIENCED LIGHTHEADEDNESS AND LOSS OF CONSCIOUSNESS. THIS PACEMAKER AND RA LEAD WERE EXPLANTED, THE RV LEAD WAS SURGICALLY ABANDONED, AND A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Loss of consciousness

  MAUDE report 11661593 ↗