FINELINE® II EZ Sterox 4472Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00802526265013), received between Jan 26, 2016 and Aug 20, 2026 — classified as 64 injuries, 18 malfunctions.

The most frequently reported specific device problem is “High impedance” (29 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351093 ↗
• InjuryMay 18, 2026Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS CUT UPON REMOVAL. THIS RA LEAD WAS EXPLANTED, REPLACED WITH DIFFERENT MODEL AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200034 ↗
• InjuryMar 16, 2026Failure to Capture; Device Sensing Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED POOR SENSING AND LOSS OF CAPTURE (LOC) AFTER THAT PATIENT HAD UNDERGONE A PROCEDURE. THIS RA LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606455 ↗
• InjuryJan 27, 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 24195944 ↗
• MalfunctionDec 4, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED AN AUTOMATIC LEAD SAFETY SWITCH (LSS) DUE TO RECORDED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS AND OVERSENSED NOISY SIGNALS CONSISTENT WITH A POSSIBLE LEAD FRACTURE. MULTIPLE ATRIAL TACHY RESPONSE (ATR) EVENTS WERE STORED DUE TO OVERSENSING, AND PAUSES GREATER THAN APPROXIMATELY TWO SECONDS WERE OBSERVED; HOWEVER, NO ASYSTOLE OCCURRED AS THE PATIENT HAD INTRINSIC CONDUCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724079 ↗
• 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22486852 ↗
• MalfunctionJun 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE SYSTEM GENERATED AN ALERT FOR AN ATRIAL LEAD IMPEDANCE > 3000 OHMS. TECHNICAL SERVICES (TS) REVIEWED THE NXT DIAGNOSTICS AND FOUND NO EVIDENCE OF ATRIAL LEAD NOISE. ALL LEAD PARAMETERS REMAINED WITHIN NORMAL LIMITS, AND THE CAUSE OF THE TRANSIENT HIGH IMPEDANCE REMAINS UNCLEAR. THERE WAS NO IMMEDIATE PATIENT IMPACT. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340756 ↗
• InjuryApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS CONFIRMED TO BE FRACTURED BY X-RAY 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 21903312 ↗
• MalfunctionMar 13, 2025Signal Artifact/Noise; Failure to Capture; Over-Sensing; Failure to Read Input Signal; Under-Sensing; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS PACEMAKER PRESENTING ELECTROGRAM (EGM) DUE TO CONCERNS OF LOSS OF CAPTURE (LOC) ON THE RIGHT ATRIAL (RA) LEAD. UPON REVIEW, INTERMITTENT RA LOC, FARFIELD R-WAVE OVERSENSING AND POSSIBLE ATRIAL UNDERSENSING WERE OBSERVED. TS RECOMMENDED TO THE HCP TO SCHEDULE AN IN PERSON VISIT FOR FURTHER DEVICE EVALUATION AND RECOMMENDED REPROGRAMMING OPTIONS. AT THIS TIME, THE PACEMAKER AND RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596404 ↗
• InjuryFeb 21, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO NOISE AND PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS, WHICH WAS HIGH OUT OF RANGE. A NEW LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432906 ↗
• MalfunctionDec 9, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS TO UNDERDOG MAGNETIC RESONANCE IMAGING (MRI). TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THE SYSTEMS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS, SO A LEAD INTEGRITY ISSUE WAS SUSPECTED AND FURTHER EVALUATION WAS RECOMMENDED, WITH THE DEVICE NOT BEEN MRI CONDITIONAL DUE TO POSSIBLE LEAD INTEGRITY ISSUES. THERE IS NO INDCIATION A MRI HAS BEEN PERFORMED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880576 ↗
• InjuryOct 1, 2024Defective Device; Defective Device

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

  Patient problems: Unspecified Infection

  MAUDE report 20349378 ↗
• InjurySep 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PHYSICIAN INADVERTENTLY SEVERED THIS RIGHT ATRIAL (RA) LEAD DURING THE GENERATOR CHANGE. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323347 ↗
• MalfunctionAug 6, 2024Signal Artifact/Noise; Over-Sensing; Device Dislodged or Dislocated; Signal Artifact/Noise; Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE THIRD-PARTY REMOTE MONITORING COMPANY REPRESENTATIVE SUSPECTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED DUE TO THE STORED ATRIAL TACHY RESPONSE (ATR) EPISODES. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THE PATIENT HAS A HISTORY OF NOISY ATRIAL FIBRILLATION (AF). THE HEALTH CARE PROFESSIONAL (HCP) CONFIRMED THE PATIENT CONDITION. HOWEVER, IT IS UNKNOWN IF THE ATRIAL TACHY RESPONSE (ATR) EPISODES PRESENTED TRUE AF OR WERE A RESULT OF OVERSENSING OF NOISY SIGNALS. TS SUGGESTED POTENTIAL FOLLOWING ACTIONS. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918401 ↗
• InjuryMay 8, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD HAD HISTORY OF HIGH OUT OF RANGE PACING IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD CHANNEL WHEN A HEALTH CARE PROFESSIONAL (HCP) CHECKED TO SEE IF THE DEVICE SYSTEM WAS MAGNETIC RESONANCE IMAGING (MRI) CONDITIONAL. TS ADVISED THAT THE DEVICE SYSTEM WOULD BE NON-MRI CONDITIONAL. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE LEAD WAS REPAIRED USING THE LEAD REPAIR KIT DURING THE GENERATOR CHANGE. ALL IMPEDANCES WERE NORMAL. THE LEAD IS NOW MRI CONDITIONAL. THE LEAD REMAINS USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270861 ↗
• InjuryMar 26, 2024Fracture; High impedance; No Apparent Adverse Event; High Capture Threshold; Fracture; High impedance; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO IMPEDANCE MEASUREMENTS OVER 3000 OHMS, HIGH CAPTURE THRESHOLDS AND FRACTURE. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980505 ↗
• MalfunctionMar 11, 2024Failure to Read Input Signal; Under-Sensing; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED IN PRESENTING AND STORED ELECTROGRAM (EGM) LIKELY A RESULT OF LOW AMPLITUDE DURING ATRIAL FIBRILLATION (AF). TO DATE, THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882832 ↗
• InjuryFeb 6, 2024Signal Artifact/Noise; Failure to Capture; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING NOISE, HIGH PACING THRESHOLDS AND LOSS OF CAPTURE. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649705 ↗
• InjuryFeb 5, 2024Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT WITH THE PACEMAKER DEVICE EXHIBITED NOISY ON THIS RIGHT ATRIAL (RA) CHANNEL. THERE WAS A SIGNAL ARTIFACT MONITOR (SAM) EPISODE NOTED AND THE ELECTROGRAM (EGM) SHOWED RA IMPEDANCE MEASUREMENTS, MEASURING LESS THAN 200 OHMS FEW MONTHS AGO. LATER, THE RA IMPEDANCES WERE GREATER THAN 3000 OHMS. IT WAS SUSPECTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD DEGRADATION. TECHNICAL SERVICES (TS) RECOMMENDED TO REDUCE RA SENSITIVITY AND CONSIDER LEAD REVISION. BOSTON SCIENTIFIC REPRESENTATIVE STATED THAT THE PHYSICIAN WAS LEANING TOWARD RA LEAD REVISION PROCEDURE, HOWEVER NO DECISION YET IS MADE. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640138 ↗
• InjuryJan 26, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WHICH WERE GREATER THAN 3000 OHMS AND HIGH PACING THRESHOLDS IN BOTH THE BIPOLAR AND UNIPOLAR CONFIGURATION. THERE WAS NOISE ON THE RA CHANNEL THAT RESULTED IN OVERSENSING AND PACING INHIBITION. IT WAS NOTED THAT THE OUT OF RANGE MEASUREMENTS WERE SUDDEN WITH SOME SPIKES. A NEW RA LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586559 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CAPPED RIGHT ATRIAL (RA) LEAD WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CAPPED RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17796199 ↗
• MalfunctionJul 5, 2023Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD HAS TRIGGERED SEVERAL LEAD SAFETY SWITCH ALERTS DUE TO PACING IMPEDANCE LOW, OUT OF RANGE. A LEAD INTEGRITY ISSUE WAS CONSIDERED. THEY HAVE THE PATIENT ON MEDICINES FOR ATRIAL ARRHYTHMIAS VARIOUS ATRIAL TACHY RESPONSE (ATR) EVENTS WERE RECORDED WHICH APPEAR AS ORIGINATED DUE TO ARTIFACT WHILE PROGRAMMED IN BIPOLAR CONFIGURATION. DIFFERENT PROGRAMMING OPTIONS WERE CONSIDERED, AND THE PATIENT WILL VISIT THE CLINIC WHERE IMPEDANCE WOULD BE SAMPLED WITH MANEUVERS. THE RA LEAD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255583 ↗
• InjuryApr 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO THE RELOCATION OF THE DEVICE AS PATIENT WAS UNDERGOING RADIATION TREATMENT. THIS LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799741 ↗
• InjuryApr 14, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT, THIS RIGHT ATRIAL (RA) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO THE LEAD EXHIBITING HIGH PACING THRESHOLDS. THE RA LEAD WAS SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748069 ↗
• InjuryMar 28, 2023Signal Artifact/Noise; Defective Device; Device Contamination with Chemical or Other Material; Signal Artifact/Noise; Defective Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD PRESENTED NOISY SIGNALS. THE PATIENT WAS EXAMINED THROUGH X-RAY IMAGING BUT NO DAMAGE WAS NOTICED. THE LEAD WAS EXAMINED AND IT WAS FOUND TO HAVE THE PROXIMAL END OF ITS INSULATION DAMAGED. THIS LEAD WAS CAPPED AND SURGICALLY ABANDONED, WITH A NEW LEAD IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632512 ↗