FINELINE II EZ SteroxRecalls & reported problems across all models

We found 6 models of FINELINE II EZ Sterox by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 5,633 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2013 and Sep 30, 2026 — classified as 36 deaths, 4,596 injuries, 1,001 malfunctions.

The most frequently reported specific device problem is “High impedance” (902 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FINELINE II EZ Sterox problems

FINELINE II EZ Sterox models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FINELINE® II EZ Sterox 4470

  permanent pacemaker Electrode
  29 deaths2,845 reports
• FINELINE® II EZ Sterox 4469

  permanent pacemaker Electrode
  5 deaths1,390 reports
• FINELINE® II EZ Sterox 4471

  permanent pacemaker Electrode
  1 death964 reports
• FINELINE® II EZ Sterox 4473

  permanent pacemaker Electrode
  1 death305 reports
• FINELINE® II EZ Sterox 4472

  permanent pacemaker Electrode
  82 reports
• FINELINE® II EZ Sterox 4474

  permanent pacemaker Electrode
  47 reports

Recent FINELINE II EZ Sterox adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that the pacemaker and this right ventricular (RV) lead exhibited a Red Call Doctor Icon (RCD). The RCD was recorded due to a high out of range pacing impedance measurement, greater than 3000 Ohms. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951587 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941323 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941320 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936903 ↗
• 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 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917394 ↗
• InjurySep 25, 2026High Capture Threshold

  It was reported that this right atrial (RA) lead was surgically abandoned due to high capture thresholds. This RA lead was successfully capped and replaced with another lead. No additional adverse patient effects were reported outside the revision procedure. This product is not expected to return.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899436 ↗
• 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 ↗
• MalfunctionSep 25, 2026Failure to Capture; High Capture Threshold

  It was reported that the pacemaker and this right ventricular (RV) lead right ventricular automatic threshold (RVAT) test was suspended due to a loss of capture. Also, Technical Services (TS) suspected this pacemaker stored inappropriate ventricular episodes due to an atrial arrythmia with rapid ventricular response (RVR). TS also noted the last RVAT was above programmed outputs and was trending upwards. TS discussed the loss of capture with the health care professional (HCP). The HCP planned to consult with cardiology. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897299 ↗
• InjurySep 25, 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. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50897005 ↗
• InjurySep 25, 2026High Capture Threshold

  It was reported prior to a gen change that this right ventricular (RV) lead exhibited a high capture threshold. Technical Services (TS) was consulted to review the ventricular leads and found pace impedance measurements within range; however, the capture threshold on the RV lead was high. The physician opted to replace the lead. 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 50896772 ↗
• MalfunctionSep 24, 2026Unexpected Therapeutic Results

  Patient problems: Bradycardia

  MAUDE report 50890075 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889297 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889292 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited increased in pacing threshold measurement post implant. The sensing was exhibiting normally, however, due to microdislodgement which was confirmed via X ray and testing this RA lead was surgically revised. At this time, this RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886216 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• ENDOTAK RELIANCE G12 models · 5,053 reports · 2 recalls