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BfArM publishes Aesculap urgent field safety notice for Ennovate C C1/C2 guide sleeve

🇩🇪 BfArM field safety notices · Thu 05 Nov 2026

The German regulator has posted a manufacturer notice on the spinal surgery instrument, but its own entry gives no detail on the defect, affected lots or required actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from Aesculap AG on 5 November 2026. It concerns the Ennovate C C1/C2 All-In-One Guide Sleeve and is filed under reference 51448/26.

BfArM lists the product group as medical instruments for use in humans, specifically bone surgery. Its entry is brief and refers readers to the manufacturer's Advisory Notice, attached as a 2MB PDF, for further information and details on the device.

The regulator's description does not state the nature of the problem, which lots or serial numbers are affected, or what users are being asked to do. Those points are not set out in the BfArM text, so they cannot be confirmed from it. The notice carries the 'urgent' designation, which indicates a field safety corrective action is under way.

As general context, a field safety notice is the manufacturer's formal communication to users of a device when it takes a field safety corrective action to reduce a risk of death or serious deterioration in health.

What it means for your team

  • Hospitals and surgical teams using the Ennovate C C1/C2 All-In-One Guide Sleeve should read Aesculap's Advisory Notice in full, as the BfArM page does not describe the issue or actions.
  • Quality and vigilance teams should check whether the device is in stock or in use at their sites and follow the manufacturer's instructions once confirmed from the notice.
  • Regulatory teams tracking field safety corrective actions should log BfArM reference 51448/26 and watch for further detail from 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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