Official recall record

AneurysmFlow

What the authority reported

Philips has determined that the mafa ratio does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment. the instructions for use (IFU) of AneurysmFlow state that the mafa ratio should not be used for making clinical decisions (section 9.2 measuring flow). In addition, when hovering over the mafa ratio header within the software interface, an on-screen message states that the mafa ratio is not to be used for clinical decision making. despite the existing cautions, the displayed mafa ratio may still be considered during intraprocedural decision-making and could influence clinical judgment. This may potentially result in an incorrect clinical decision.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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