FINELINE® II EZ Sterox 4473Recalls & reported problems

Summary

The FDA's MAUDE database contains 305 adverse event reports that list this exact device (DI 00802526265020), received between Apr 25, 2016 and Sep 29, 2026 — classified as 1 death, 243 injuries, 61 malfunctions.

The most frequently reported specific device problem is “High impedance” (91 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 305 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited high pacing thresholds. The physician believed cause to be due to fibrosis at lead tip due to age of the lead. A revision procedure was performed. This RV lead was surgically abandoned and replaced with a new lead successfully. No additional adverse patient effects were reported.

  Patient problems: Fibrosis

  MAUDE report 50927560 ↗
• MalfunctionSep 25, 2026Signal Artifact/Noise; High impedance

  It was reported that this right atrial (RA) lead exhibited high out of range pacing impedance measurements. The rep confirmed the impedances spiked out of range about three times over the past year and then returned to normal. Technical Services (TS) recommended isometrics to test the lead integrity. There was noise present that was not oversensed. This lead has been recommended for replacement. This RA lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899034 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50678276 ↗
• MalfunctionSep 4, 2026Failure to Capture; High impedance; Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610766 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600379 ↗
• InjuryJul 1, 2026Signal Artifact/Noise; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS DAMAGED DURING GENERATOR CHANGE OUT AND OUTER CONDUCTOR FRACTURE WAS SUSPECTED. ALSO, THE LEAD EXHIBITED PACING LEAD IMPEDANCE OF MORE THAN 3000 OHMS WITH LEAD NOISE BIPOLAR. THE UNIPOLAR PACING AND SENSING WERE REPROGRAMMED. TO DATE, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674410 ↗
• InjuryJun 22, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS DUE TO A LEAD SAFETY SWITCH. ADDITIONALLY, THE SYSTEM HAD PREVIOUSLY EXHIBITED OVERSENSING. TECHNICAL SERVICES (TS) WAS CONSULTED BY THE LOCAL FIELD REPRESENTATIVE TO DETERMINE IF A NEW SYSTEM WAS NEEDED. TS NOTED THE PATIENT WAS DEPENDENT AND THAT OVERSENSING HAD PREVIOUSLY OCCURRED AND FURTHER OFFERED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD IS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580017 ↗
• InjuryMay 29, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ON THE RIGHT ATRIAL (RA) LEAD DUE TO A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. AS A RESULT, THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT) TEST WAS SUSPENDED, AND MINUTE VENTILATION (MV) WAS DISABLED. ADDITIONALLY, INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES WERE STORED DUE TO OVERSENSED NOISE ON THE LEAD. IT WAS FOUND THAT THIS LEAD WAS FRACTURED. THE PATIENT EXPERIENCED WORSENING FATIGUE, LIGHTHEADEDNESS, DYSPNEA, AND LOWER EXTREMITY EDEMA. FOLLOWING THE WORSENING SYMPTOMS, THE PATIENT'S MEDICATIONS WERE INCREASED. IT WAS NOTED THAT THIS PATIENT IS PACEMAKER DEPENDENT AND HAS A HISTORY OF VENOUS INSUFFICIENCY. SUBSEQUENTLY, THIS LEAD WAS CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Dyspnea; Fatigue; Swelling/ Edema

  MAUDE report 25334409 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER RA LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260646 ↗
• InjuryMay 9, 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. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25132865 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER ENTERED INTO SAFETY MODE AND WAS NOT ABLE TO BE INTERROGATED. THE PACEMAKER HAS BEEN EXPLANTED AT THIS TIME AND A NEW PACEMAKER IMPLANTED. ALSO THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AT THE SAME PROCEDURE DUE TO A NON SPECIFIC ALLEGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124894 ↗
• InjuryMay 6, 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 25096575 ↗
• 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. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD VEGETATION IN THE LEFT VENTRICLE GROWING ON THE MITRAL LEAFLETS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24715588 ↗
• MalfunctionMar 25, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH WAS NOTED IN THE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT THE PACING IMPEDANCE WAS STABLE IN THE 500 OHMS RANGE AND THAT THE PRESENTING ELECTROGRAM DID NOT SHOW ANY NOISE. THE CLINICIAN STATED THAT THE PATIENT HAS DEMENTIA AND HAS NOT BEEN SEEN IN THE CLINIC. DURING A SUBSEQUENT CALL, TS INDICATED THAT THE AVAILABLE DATA SUGGESTED A POTENTIAL LEAD ISSUE, POSSIBLY REFLECTING EARLY STAGES OF LEAD FAILURE GIVEN THAT THE LEAD HAS BEEN IMPLANTED FOR MORE THAN 20 YEARS. NOISE WAS OBSERVED ON THE RV CHANNEL, AND PROGRAMMING OPTIMIZATION WAS PERFORMED; HOWEVER, THE NOISE REMAINED VISIBLE ALTHOUGH IT WAS NOT BEING SENSED. TS RECOMMENDED CONTINUED MONITORING AND ADVISED BRINGING THE PATIENT INTO THE CLINIC FOR FURTHER TESTING AND POTENTIAL REPROGRAMMING. TS ALSO NOTED THAT THE PATIENT MAY ULTIMATELY REQUIRE A NEW LEAD. IT WAS LATER REPORTED THAT THE PATIENT WAS EVALUATED IN THE CLINIC, WHERE RV OVERSENSING WAS OBSERVED DURING ISOMETRICS. PROGRAMMING OPTIMIZATION WAS PERFORMED, AFTER WHICH NO REPRODUCIBLE RV LEAD NOISE OVERSENSING WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688708 ↗
• InjuryMar 2, 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 STAPHYLOCOCCUS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 24490764 ↗
• InjuryJan 21, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THIS RV LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133314 ↗
• InjuryOct 1, 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 WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23196901 ↗
• MalfunctionSep 11, 2025Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Under-Sensing; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES MEASURING ABOVE 2500 OHMS, WITH UNDERSENSING, HIGH PACING THRESHOLDS, NOISE, AND SUSPECTED LOSS OF CAPTURE WITH AN ATRIAL RHYTHM OF 30 BEATS PER MINUTE CAUSED BY A LEAD FRACTURE. TECHNICAL SERVICES (TS) WAS CONSULTED, AND PROGRAMMING OPTIONS WERE ADVISED. THE PHYSICIAN OPTED TO PERFORM THE PROGRAMMING ENHANCEMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: Bradycardia

  MAUDE report 23026321 ↗
• InjurySep 10, 2025Difficult to Remove; Defective Device; Material Integrity Problem; Difficult to Remove; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED TO BE REMOVED DUE TO THE EXTRACTION OF THE OLDER NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. THE RA LEAD WAS BROKEN DURING EXTRACTION ATTEMPTED AND IT WAS SURGICALLY ABANDONED. THE NON-BSC RV LEAD WAS ABANDONED AS WELL. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED TWO NEW LEADS WHILE USING THE CURRENT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23019942 ↗
• InjurySep 4, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE OUT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE. IT WAS NOTED THAT THERE WAS NO PACING AT MAXIMUM OUTPUTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEAD. THIS RV LEAD HAS NOT BEEN RETURNED FOR ANALYSIS AND THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22972775 ↗
• InjuryAug 29, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCES AND LEAD SAFETY SWITCH (LSS). TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING CHANGES FOR THIS LEAD. AFTER REPROGRAMMING, LSS OCCURRED AGAIN, AND HIGH CAPTURE THRESHOLDS WERE NOTED, WHICH THE PATIENT FELT. TS RECOMMENDED CHECKING THE SET SCREW WITH THE HEADER FOR THE PACEMAKER. POCKET REVISION WAS SCHEDULED FOR THE PATIENT. THIS LEAD AND PACEMAKER REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22923080 ↗
• MalfunctionAug 25, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. TECHNICAL SERVICES (TS) ADVISED NOISE WAS OVERSENSED AND RESULTED IN INAPPROPRIATE ATRIAL TACHY RESPONSE EPISODES TO BE STORED. TS ALSO FOUND TWO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TS ALSO FOUND EVIDENCE OF RESPIRATORY RATE TREND OVERSENSING. THE PATIENT WAS SEEN IN CLINIC. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED NOISE CAN BE REPRODUCED WITH ISOMETRICS. THE HCP COMPLETED REPROGRAMMING SUGGESTED BY TS. THE HCP PROVIDED THEY WOULD CONTINUE TO MONITOR THE PATIENT AT THIS TIME. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884278 ↗
• InjuryAug 15, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLDS. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RA LEAD HAD NO CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813710 ↗
• MalfunctionAug 5, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD WAS EXHIBITING ATRIAL FIBRILLATION (AF) SINCE JUNE. HIGH CAPTURE THRESHOLD AND LOSS OF CAPTURE (LOC) WERE NOTED. THE PERSISTENT AF ARE CONTRIBUTING TO A DROP IN DEVICE LONGEVITY. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716291 ↗
• InjuryJun 27, 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. REPORTEDLY, THE PATIENT HAD A LEAD FRACTURE, A SUBCLAVIAN CRUSH. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 22347268 ↗