The Recall Desk
HighFDA (Devices)·Z-1805-2026·Announced 2026-04-22

[pending] Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent

Pending LLM rewrite. Source: FDA_DEVICE Z-1805-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (01)00884838099272(21)67
  • (01)00884838099272(21)675
  • (01)00884838085367(21)178
  • (01)00884838099272(21)112
  • (01)00884838085367(21)335
  • (01)00884838116801(21)345
  • (01)00884838085367(21)147
  • (01)00884838085367(21)205
  • (01)00884838099272(21)113
  • (01)00884838099272(21)121
  • (01)00884838116801(21)24
  • (01)00884838085367(21)170
  • (01)00884838099258(21)1150
  • (01)00884838116801(21)17
  • (01)00884838116801(21)25
  • (01)00884838059061(21)639
  • (01)00884838085268(21)856
  • (01)00884838116801(21)180
  • (01)00884838116801(21)227
  • (01)00884838099272(21)239

Distribution

Distributed nationwide across the United States.

Related recalls

Same category