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BfArM lists urgent field safety notice for BS Medical Tech ureteral stent and nephrostomy kits

🇩🇪 BfArM field safety notices · Mon 02 Nov 2026

German regulator publishes a BS Medical Tech notice covering Tumorstent, Innoflex, Innosoft, Innostar, Percudrain and Percusof kits, but the listing gives no details of the problem.

Germany's medicines and devices authority BfArM has published an Urgent Field Safety Notice from BS Medical Tech Industry on 2 November 2026. It is filed under reference 50760/26 in the product group 'non-active implants – special implants'.

The notice names nine kit variants: IMP Tumorstent, Innoflex Mono-J, Innoflex Ureteral stent, Innosoft Mono-J, Innosoft Ureteralstent, Innostar Ureteralstent, Percudrain 2 step nephrostomy, Percudrain 3 and Percusof.

The BfArM listing does not describe the issue behind the notice, the affected batches or the action users are expected to take. It refers readers to the manufacturer's enclosed Advisory Notice, available as a 467 KB PDF download. BfArM notes that the file does not meet accessibility standards.

As general context, a field safety notice is the manufacturer's communication to users about a corrective action concerning a marketed medical device. Regulators typically post these notices so that healthcare providers and distributors can see them.

What it means for your team

  • Teams handling the named kits should obtain and read the manufacturer's Advisory Notice, as the BfArM listing gives no details of the issue or required actions.
  • Quality and vigilance staff should check whether affected products are held in stock or used in their facilities, using reference 50760/26 for traceability.
  • Any conclusions about risk, affected lots or corrective measures must wait until the Advisory Notice has been reviewed.

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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