Quality & complianceOfficial

BfArM lists urgent field safety notice for Boston Scientific's OptiCross intravascular ultrasound device

🇩🇪 BfArM field safety notices · Wed 21 Oct 2026

Germany's medicines and devices authority has published a Boston Scientific field safety notice for OptiCross, but the listing itself does not describe the problem or the action required.

BfArM, the German federal institute for drugs and medical devices, has published an Urgent Field Safety Notice from Boston Scientific Corporation of Marlborough concerning its OptiCross device. The entry is dated 21 October 2026 and carries the reference 49070/26.

The listing places the product in the group 'Ultrasonics - ultrasonic diagnostic equipment'. It directs readers to the manufacturer's Advisory Notice for further information and details on the device. That notice is attached as a PDF of 423KB, which the page says does not meet accessibility standards.

The BfArM entry does not say what prompted the notice. It also gives no information on affected lots or serial numbers, the clinical risk, or the corrective actions the manufacturer is asking users to take. Those details are expected to be in the attached Advisory Notice, which was not reproduced in the listing.

For context, a field safety notice is the communication a manufacturer sends to customers and users when it takes a field safety corrective action on a marketed medical device. National authorities such as BfArM publish these notices on their websites.

What it means for your team

  • Download and read the full Boston Scientific Advisory Notice (ref. 49070/26) before drawing any conclusions; the BfArM listing contains no detail on the issue.
  • Quality and supply teams at hospitals and distributors should check whether OptiCross devices are held in stock or in use, and compare them against the lot information in the manufacturer's notice.
  • Vigilance and regulatory staff should log the notice in their field safety corrective action tracking and confirm any required response or acknowledgement with the manufacturer.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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