Official recall notice
FDA Recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent
- Recall date
- 2026-04-22
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Recommended action
What to do
1,033 units
Product description
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.