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Intersurgical breathing systems: connectors can detach from Smoothbore tube, IGJ posts safety notice

🇳🇱 IGJ · Thu 12 Nov 2026

The Dutch inspectorate has published a manufacturer field safety notice after reports of soft connectors coming off Intersurgical's sterile and non-sterile breathing systems.

The Dutch healthcare inspectorate IGJ has published a field safety notice (FSN) from Intersurgical Ltd covering its sterile and non-sterile breathing systems. The notice is dated 28 October 2026, and the IGJ listing carries a warning date of 13 November 2026. The authorised representative named is UAB Intersurgical.

During manufacture, tetrahydrofuran (THF) solvent is used to bond the soft connectors onto the Smoothbore tube. The manufacturer says it received reports from the market of soft connectors disconnecting from the tube.

Intersurgical investigated and tested internal stock. It concluded that an insufficient amount of solvent had been used to ensure a secure connection. The excerpt available does not say which batches or products are affected.

The text provided does not set out the corrective actions requested of users or distributors. These will be in the full six-page English PDF attached to the IGJ notice. A disconnection in a breathing circuit is a patient safety concern, so the full notice should be read promptly.

As general context, manufacturers must monitor their devices after they are placed on the market and act where users are at risk. They inform users and the competent authority through a field safety notice.

What it means for your team

  • Hospitals and distributors that hold Intersurgical sterile or non-sterile breathing systems should obtain the full FSN from IGJ and check the affected products and any requested actions.
  • Quality and risk teams should check stock and incident records for reports of connector disconnection from the Smoothbore tube.
  • The excerpt does not state affected lots or the required corrective actions, so teams should not assume the scope until they have read the complete notice.
  • Regulatory teams should note the root cause as stated: an insufficient amount of THF solvent in bonding, identified through internal stock testing.

Official source: IGJ ↗

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

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