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Boston Scientific updates OptiCross IVUS catheter instructions after air embolism and repeated-flushing reports

🇳🇱 IGJ · Mon 09 Nov 2026

The manufacturer is revising the instructions for use of its OptiCross intravascular ultrasound imaging catheters, according to a field safety notice published by the Dutch inspectorate IGJ.

Boston Scientific is updating the instructions for use (IFU) for its OptiCross intravascular ultrasound imaging catheters. The Dutch healthcare inspectorate IGJ has published the manufacturer's warning on its website, dated 10 November 2026.

According to the notice, the changes follow two types of reports: cases of air embolism, and cases in which users flushed the catheter repeatedly to restore image quality while it was still inside the patient's body.

The field safety notice (FSN) itself is dated 22 October 2026. The IGJ listing names Boston Scientific Corporation as manufacturer and Boston Scientific Limited as its authorised representative. The accompanying PDF runs to seven pages. The text available to VigiEye does not set out the specific wording of the IFU revisions, the affected product codes or lots, or any other requested user actions.

IGJ presents the item as a manufacturer's warning. As general context, manufacturers must monitor devices after they reach the market and act where a risk to users emerges. They inform users and the inspectorate through a field safety notice.

What it means for your team

  • Hospital and cath-lab users should obtain the full FSN and revised IFU from the IGJ listing or from Boston Scientific, and check the details of the changes against current practice.
  • Vigilance teams should review any local incident reports involving air embolism or repeated flushing during OptiCross use, and consider whether these should be reported.
  • Quality and regulatory staff should confirm that the revised IFU is distributed and that any training materials or procedures referring to catheter flushing are updated as needed.
  • The summary does not specify the scope of affected devices or required actions, so teams should rely on the full notice rather than this summary.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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