FINELINE® II EZ Sterox 4470Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,845 adverse event reports that list this exact device (DI 00802526264993), received between Jun 18, 2014 and Sep 29, 2026 — classified as 29 deaths, 2,387 injuries, 429 malfunctions.

The most frequently reported specific device problem is “High impedance” (410 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 2,845 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941323 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936903 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 24, 2026Failure to Read Input Signal; Under-Sensing

  It was reported that this right atrial (RA) lead was exhibited under sensing and low intrinsic amplitude. Boston Scientific Technical Services (TS) recommended considering increasing RA sensing. This lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880413 ↗
• InjurySep 23, 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 50873136 ↗
• InjurySep 23, 2026Fracture

  It was reported that this right atrial (RA) lead was surgically abandoned due to a fracture that occurred during the changeout procedure for the device. All measurements prior to the fracture were within normal limits, but the field representative elected for a new lead as the fracture occurred inside the lead. A new lead was successfully implanted. No additional adverse patient effects were reported. This RA lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872789 ↗
• 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 50801884 ↗
• InjurySep 16, 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 50784074 ↗
• InjurySep 15, 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 was no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50777452 ↗
• InjurySep 15, 2026Failure to Capture; Fracture; Impedance Problem

  It was reported that this right ventricular (RV) lead was explanted and replaced. No additional adverse patient effects were reported.Additional information was received. This RV lead was explanted due to subclavian crush.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773883 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) and right atrial (RA) lead was notified by their clinic of an alert associated with the implanted system. Technical Services (TS) was consulted; however, it could not be determined whether the alert was related to impedance measurements or signal amplitude measurements. The patient was subsequently evaluated in clinic, where noise was observed on the left ventricular (LV) channel. The local company representative performed troubleshooting to further assess the condition. Additionally, the patient reported that following the initial implant procedure, there had been fluid accumulation around the device and that the leads had perforated; however, no additional details regarding these reported events were available. This RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Cardiac Perforation

  MAUDE report 50708699 ↗
• InjurySep 9, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was surgically explanted due to fracture. No new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50690073 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50643016 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a generator change procedure, this right ventricular (RV) lead was surgically abandoned due to unknown other non-product experience. A new lead was implanted as a replacement successfully. No additional adverse patient effects were reported. This RV lead was capped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613288 ↗
• InjurySep 4, 2026High impedance; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited high impedance measurements and high thresholds. The lead was surgically abandoned and replaced as a result. No additional adverse patient effects were reported. This RA lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602188 ↗
• InjurySep 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was capped and replaced due to nonspecific product performance anomalies. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602179 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was explanted due to unknown reasons. Additional information was requested but unable to be obtained at this time. No additional adverse patient effects were reported. This LV lead has not been returned for analysis.Additional information was received and it was reported that this lead that was explanted was the right ventricular (RV) lead. This lead was explanted due to physician preference, and no anomalies were noted with the lead. No additional adverse patient effects were reported. This RV lead has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600407 ↗
• InjurySep 4, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  Patient problems: Dizziness

  MAUDE report 50600227 ↗
• MalfunctionSep 2, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566116 ↗
• InjuryAug 24, 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 50420755 ↗
• InjuryAug 22, 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 50386971 ↗
• InjuryAug 21, 2026Signal Artifact/Noise; High impedance; Insufficient Device Problem Information; High Capture Threshold

  It was reported that this right atrial (RA) lead was explanted due to a Product Performance Issue. This RA lead was successfully extracted and replaced with another lead. No additional adverse patient effects were reported outside the revision procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361972 ↗