Neuroform Atlas M003UZAS45300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327382129), received between Sep 1, 2020 and Oct 24, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT THROUGH THE MICROCATHETER A POP SOUND OCCURRED, AND THE PHYSICIAN NOTICED THAT THE STENT DELIVERY WIRE COULD BE MOVED INDEPENDENTLY WHILE THE STENT MARKERS WERE STATIONARY INDICATING STENT DEPLOYMENT WITHIN THE MICROCATHETER. THE SURGERY WAS PROLONGED BY 10 MINUTES. 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 23376688 ↗
• MalfunctionJul 10, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, THE SUBJECT STENT WAS PREMATURELY DEPLOYED ABOUT 5 INCHES FROM THE DISTAL TIP OF THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND 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 22470958 ↗
• InjuryJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT (SUBJECT DEVICE) THE DELIVERY WIRE OF THE STENT WAS FRACTURED. SURGICAL REMOVAL WAS ATTEMPTED BUT THE FRAGMENTS OF FRACTURED PIECES REMAINED WITHIN THE PATIENT'S BODY AND THE PATIENT IS IN COMA.

  Patient problems: Coma; Foreign Body In Patient

  MAUDE report 22371619 ↗
• MalfunctionJun 10, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS SELECTED FOR TREATMENT AT INTERNAL CAROTID ARTERY (ICA). WHEN THE PHYSICIAN WAS ADVANCING THE SUBJECT DEVICE AND REALIZED THE SUBJECT DEVICE WAS NOT ON THE DELIVERY SYSTEM. THE SUBJECT DEVICE WAS INSIDE THE CATHETER. THE SUBJECT DEVICE WAS REPLACED WITH A NEW DEVICE 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 22180550 ↗
• MalfunctionFeb 4, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, SUBJECT STENT PREMATURELY DEPLOYED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308301 ↗
• MalfunctionSep 20, 2024Premature Activation; Premature Activation

  THE STENT (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT STENT WAS PREMATURELY DEPLOYED DURING USE. 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 20268028 ↗
• MalfunctionNov 22, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING BRAIN ANEURYSM PROCEDURE, 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 18189862 ↗
• MalfunctionApr 25, 2022Premature Activation; Premature Activation

  IT WAS REPORTED DURING THE PROCEDURE THAT THE SUBJECT STENT CAME OFF THE CUSHER WIRE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197882 ↗
• MalfunctionSep 24, 2021Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT STENT PREMATURELY DEPLOYED DURING USE. 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 12527117 ↗
• MalfunctionSep 1, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RO MARKER CAME LOOSE AND MIGRATED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 INDICATED THAT THE SUBJECT STENT WAS IMPLANTED IN THE LEFT M2 AND JUST THE RO MARKER OF THE STENT DETACHED AND MIGRATED AWAY FROM THE TARGET SITE. THE RO MARKER WAS LEFT INSIDE THE PATIENT VASCULATURE. NO MEDICAL INTERVENTION WAS PERFORMED DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10480791 ↗