AneurysmFlow Medical Device Recall - Unreliable mafa Ratio
Summary
Health Canada issued a Type II recall for AneurysmFlow software (Model 1.4) manufactured by Philips Medical Systems Nederland B.V. The recall addresses unreliable mafa ratio measurements that provide inaccurate prognostic information for aneurysm occlusion following flow diverter stent treatment. Despite existing cautions in the instructions for use, the displayed mafa ratio may still influence intraprocedural clinical decisions, potentially resulting in incorrect patient treatment choices.
What changed
Philips Medical Systems has issued a Type II recall for AneurysmFlow software version 1.4 after determining that the mafa ratio does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment. The product's instructions for use (Section 9.2) and on-screen warnings already caution against using the mafa ratio for clinical decision-making, yet Health Canada and Philips identified that intraprocedural reliance on this metric may still occur and could influence clinical judgment, risking incorrect treatment decisions. Identification number: RA-81836.
Healthcare providers using AneurysmFlow version 1.4 should immediately review the existing cautions in the instructions for use and ensure staff do not rely on the mafa ratio for clinical decision-making during procedures. Providers should contact Philips Medical Systems directly for additional information regarding the recall and any available software corrections. Facilities should review their inventory and update internal protocols to explicitly prohibit mafa ratio use in treatment planning until a corrected version is available.
What to do next
- Review AneurysmFlow instructions for use Section 9.2 measuring flow and ensure staff understand the mafa ratio should not be used for clinical decisions
- Update internal protocols to explicitly prohibit reliance on mafa ratio measurements for treatment planning
- Contact Philips Medical Systems at the provided address for additional information and potential software corrections
Source document (simplified)
Health product recall
AneurysmFlow
Brand(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Last updated
2026-04-02
Summary
Product AneurysmFlow Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| AneurysmFlow | Not applicable. | 1.4 |
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
Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-03-25
Identification number RA-81836
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