Public recall detail

AneurysmFlow

2026-04-02

medium
General hospital and personal use Performance
Quick summary

Quick summary: AneurysmFlow. Reason: Performance. Category: General hospital and personal use. Date: 2026-04-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: AneurysmFlow. Reason: Performance. Category: General hospital and personal use. Date: 2026-04-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductAneurysmFlow
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81836

Affected products

ProductAneurysmFlow
LotNot applicable.
Model1.4
Serial numberNot applicable.
DescriptionAneurysmFlow

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Recall date2026-03-25
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81836
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2026-04-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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