Neuroform Atlas M003UZAS30150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327382228), received between Mar 30, 2020 and Apr 15, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Activation Failure

  IT WAS REPORTED THAT PATIENT UNDERWENT STENTING PROCEDURE OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM. DURING DEPLOYMENT, ONE OF STRANDS EXTENDED BEYOND THE PROXIMAL LANDING ZONE AFTER THE SUBJECT STENT WOULDN'T OPEN UP. THE PHYSICIAN TRIED TO AGITATE THE PROXIMAL END OF THE SUBJECT STENT THAT WASN'T OPENING AND THE PROCEDURE WAS COMPLETED. THE SUBJECT STENT REMAINS IMPLANTED IN THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886759 ↗
• MalfunctionNov 26, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT STENT WAS NOT OPENING PROPERLY. 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 23657486 ↗
• MalfunctionAug 29, 2024Premature Activation; Premature Activation

  I T WAS REPORTED THAT THE SUBJECT STENT DEPLOYED PREMATURELY DURING THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20102982 ↗
• MalfunctionMay 24, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT (SUBJECT DEVICE) DEPLOYED PREMATURELY IN THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873812 ↗
• MalfunctionApr 2, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE DELIVERING THE STENT THROUGH THE GUIDE CATHETER, THE SUBJECT STENT WAS NOTED MISSING ON THE DELIVERY WIRE AND WAS NOT CONFIRMED UNDER FLUOROSCOPY. THE PROCEDURE WAS STOPPED AND THE PHYSICIAN WILL RE-ATTEMPT TO PERFORM THE PROCEDURE IN TWO WEEKS. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT AND THE PATIENT WAS NOT AFFECTED AS A RESULT OF THE SURGICAL DELAY OR THE DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918848 ↗
• MalfunctionMar 30, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) WAS MISSING, AFTER FURTHER INVESTIGATION, IT IS SUSPECTED THAT MICROCATHETER USED WAS TOO BIG AND STENT (SUBJECT DEVICE) HAD POSSIBLY DEPLOYED AT THE BASE OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900068 ↗