Health Canada2 Apr 2026
AneurysmFlow
Health Canada published a recall notice for AneurysmFlow on 2 Apr 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 2 Apr 2026
- Recall type
- Health product recall
- Companies
- Philips Medical Systems Nederland B.V. · Veenpluis 6, Best, Netherlands, 5684 PC
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-04-02 Affected products: Affected products Lot or serial number Model or catalogue number AneurysmFlow Not applicable. 1.4 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.