Market accessOfficial

Abiomed warns of Impella controller failures to recognise purge cassette

🇳🇱 IGJ · Sun 08 Nov 2026

Abiomed has reported more complaints that its Automated Impella Controller fails to detect the purge cassette, which it links to defects in a purge pressure sensor component.

Abiomed has identified a rise in complaints about its Automated Impella Controller (AIC) failing to recognise the purge cassette, according to a field safety notice published by the Dutch health inspectorate, IGJ.

The manufacturer attributes the problem to defects in the purge detection component of the purge pressure sensor assembly. The notice is dated 1 August 2026, and the IGJ entry carries a date of 9 November 2026 for the downloadable warning, a 10-page PDF.

Abiomed Inc. is named as the manufacturer and Abiomed Europe GmbH as its authorised representative. The listing does not set out in its text which specific actions users must take, so those details are contained in the full notice.

As background, manufacturers are required to monitor their devices after they reach the market and to act where a risk to users emerges. They inform users and regulators of such actions through a field safety notice.

What it means for your team

  • Hospitals and users of the Automated Impella Controller should read the full 10-page field safety notice to identify any required actions.
  • Quality and vigilance teams should check complaint records for purge cassette recognition problems and make sure these are reported and handled in line with the notice.
  • Regulatory affairs teams in Europe should confirm that the notice has been received and that any follow-up with Abiomed Europe GmbH is documented.

Official source: IGJ ↗

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

More Market access All →