Neuroform Atlas M003UZAS40210Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327382174), received between Feb 18, 2020 and Jul 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841258 ↗
• MalfunctionApr 20, 2026Premature Activation

  IT WAS REPORTED THAT THE SUBJECT STENT WOULD NOT GO THROUGH THE MICROCATHETER. THE SUBJECT STENT WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT STENT HAD DEPLOYED PREMATURELY DURING USE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929832 ↗
• MalfunctionJan 28, 2026Difficult or Delayed Activation

  THE SUBJECT STENT WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED STENT PARTIAL DEPLOYMENT .THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200460 ↗
• MalfunctionMar 11, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING ANEURYSM STENT COIL PROCEDURE THE OPERATOR WAS ADVANCING THE SUBJECT STENT THROUGH THE MICROCATHETER. FRICTION WAS NOTED WHEN ADVANCING THE SUBJECT STENT TO THE TARGET LESION AND FLUOROSCOPY SHOWED THAT NO SUBJECT STENT WAS PRESENT ON THE DELIVERY WIRE. IT WAS CONCLUDED THAT THE SUBJECT STENT DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881908 ↗
• MalfunctionDec 5, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT STENT WAS PARTIALLY DEPLOYED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267082 ↗
• MalfunctionMay 26, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE STENT (SUBJECT DEVICE) WAS DELIVERED THROUGH A MICROCATHETER, IT PREMATURELY DETACHED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520047 ↗
• MalfunctionMay 26, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE STENT (SUBJECT DEVICE) WAS DELIVERED THROUGH A MICROCATHETER, IT PREMATURELY DETACHED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519974 ↗
• MalfunctionFeb 25, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT WAS PARTIALLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO RESHEATH AND REPOSITION THE SUBJECT DEVICE BUT WAS UNABLE TO RESHEATH. WHILE THE SUBJECT STENT WAS BEING WITHDRAWN, IT GOT DEPLOYED PREMATURELY INSIDE THE RHV OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382336 ↗
• MalfunctionFeb 18, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE STENT (SUBJECT DEVICE) IN THE MICROCATHETER. THE SALES REPRESENTATIVE HAD THE PHYSICIAN PULL THE STENT OUT AND DISCARDED IT. THERE WERE NO PATIENT CLINICAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9723131 ↗