Philips AneurysmFlow Software
Philips is recalling AneurysmFlow software due to unreliable MAFA ratio data that may lead to incorrect clinical treatment decisions.
Clinicians should stop using the MAFA ratio feature for making clinical decisions regarding aneurysm occlusion. Contact your local Philips representative for further instructions and software updates.
Why it was recalled
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.
How to identify it
UPC 00884838099272 00884838099272 00884838099272 00884838085367 00884838099272 00884838085367 00884838116801 00884838085367
Philips AneurysmFlow. Model Number: 001015.
Where it was sold
Distributed in US.
Official source
Other recent recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification