PharmacovigilanceOfficial

Getinge flags software D.03 issue that may stop Cardiosave balloon pumps starting therapy

🇳🇱 IGJ · Tue 03 Nov 2026

A Dutch inspectorate notice says Getinge's D.03 software slows the compressor during autofill, potentially lowering vacuum and triggering an alarm that prevents Cardiosave pumps from starting or resuming therapy.

Getinge has identified a software problem affecting Cardiosave intra-aortic balloon pumps (IABPs) that run software version D.03, according to a manufacturer warning published by the Dutch Health and Youth Care Inspectorate (IGJ).

The notice says the D.03 software reduces compressor speed during an autofill cycle. That may lower the vacuum level in the system. Depending on how well the system maintains vacuum, the pump may raise an Autofill Failure Alarm and may be unable to start or resume therapy.

The product is listed as Cardiosave Intra-Aortic Balloon Pumps from manufacturer Datascope Corp. The authorised representative is Maquet Critical Care AB. The field safety notice (FSN) is dated 3 October 2026, and the IGJ page carries a date of 4 November 2026. The English-language download runs to 16 pages.

The IGJ page does not detail the corrective actions, the number of devices affected or any reported patient harm. Those points are presumably covered in the full FSN, which the inspectorate links as a PDF but which is not reproduced in the text available here.

As context, a field safety notice is the means by which a manufacturer informs users and the competent authority of action it is taking after identifying a risk linked to a device already on the market.

What it means for your team

  • Hospitals and distributors should check whether any Cardiosave IABPs run software version D.03 and consult the full FSN for instructions.
  • Vigilance teams should log the FSN dated 3 October 2026 and track the manufacturer's corrective action and any follow-up communication.
  • Clinical engineering and risk teams may wish to review how an Autofill Failure Alarm, and the resulting inability to start or resume therapy, is handled in local procedures.
  • The scope, number of units and corrective measures are not stated in the IGJ summary, so teams should rely on the full notice.

Official source: IGJ ↗

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

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