Quality & complianceOfficial

BfArM publishes urgent field safety notice for Shockwave Medical's Shockwave Reducer

🇩🇪 BfArM field safety notices · Tue 10 Nov 2026

Germany's medicines and devices regulator has listed a manufacturer notice for the Shockwave Reducer, but the nature of the problem is only in the attached Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Shockwave Medical covering the Shockwave Reducer. The entry is dated 10 November 2026 and carries the reference 51153/26.

BfArM classifies the product under non-active implants, specifically special implants. The regulator's listing is brief and does not describe the underlying issue, the affected lots or serial numbers, or the actions users are asked to take.

Instead, the page directs readers to the manufacturer's Advisory Notice for further information and device details. That document is provided as a PDF of 491KB, which BfArM notes does not meet accessibility standards.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action on a device already on the market. Regulators such as BfArM publish these notices so that affected facilities can find them.

What it means for your team

  • Users of the Shockwave Reducer should read the full manufacturer Advisory Notice, as the BfArM listing does not state the issue or required actions.
  • Vigilance and QA teams should check whether any affected product is held in their facilities and record the notice under their field safety corrective action procedures.
  • Until the notice is reviewed, the scope, affected lots and any deadlines for response remain unknown from the BfArM entry alone.

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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