Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36736 |
| Brand Name: | AnerysmFlow_Interventional Tool [MDR] |
| Model: | Philips AneurysmFlow |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems Nederland BV |
| Issue: | The manufacturer 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 intra-procedural decision-making and could influence clinical judgment. This may potentially result in an incorrect clinical decision. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/4/2026 |
