Neuroform Atlas M003UZAS40240Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327382167), received between Mar 5, 2021 and Apr 1, 2025 — classified as 1 death, 1 injury, 4 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.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE LEFT P1 OCCLUSION WAS OBSERVED AS IT WAS TREATED WITH INTRA-ARTERIAL EPTIFIBATIDE AND SECOND STENT WAS PLACED IN THE P1. THE EVENT WAS RESOLVED, WITHOUT SEQUELAE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21749060 ↗
• MalfunctionDec 7, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT SUBJECT STENT WAS DETACHED IN DISTAL PART OF CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873539 ↗
• MalfunctionNov 26, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT WAS NOT ON THE DELIVERY WIRE. 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 20787763 ↗
• MalfunctionOct 29, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT DETACHED FROM THE DELIVERY WIRE 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 20560173 ↗
• MalfunctionJan 19, 2023Premature Activation; Premature Activation

  THE STENT (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE STENT (SUBJECT DEVICE) WAS RETURNED DEPLOYED WITHIN 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 16212085 ↗
• DeathMar 5, 2021Activation Failure; Migration; Activation Failure; Migration

  ADDITIONAL INFORMATION REQUEST MDR 2400040000-2021-8011-FDA LETTER.MSG AND MEDWATCH UF/IMPORTER REPORT #2400040000-2021-8011 REVIEWED ON 09-FEB-2021 REPORTED THAT DURING AN ELECTIVE STENT ASSISTED COIL EMBOLIZATION PROCEDURE OF THE RIGHT INTERNAL CAROTID ARTERY (R ICA) ANEURYSM ON A 36 YEAR OLD FEMALE PATIENT, THE SUBJECT STENT HAD A COLLAPSED END AFTER DEPLOYMENT. WHEN ANEURYSM COILING WAS ATTEMPTED, THE SUBJECT STENT DEFORMED AND LED TO AN INABILITY TO EMBOLIZE THE ANEURYSM AND SUBSEQUENT ANEURYSMAL RUPTURE. PHYSICIAN REPORTED THAT NOTHING OCCURRED DURING THE CASE THAT WOULD EXPLAIN THE MALFUNCTION. THE PHYSICIAN PLACED A BALLOON EXPANDABLE STENT, AFTER ATTEMPTS TO RETRIEVE THE SUBJECT STENT WERE UNSUCCESSFUL. SHEATHS WERE REPORTED TO HAVE BEEN LEFT IN PLACE BUT IT IS UNKNOWN WHAT THIS MEANS. THE PROCEDURE WAS ALSO COMPLICATED BY SUBSEQUENT RIGHT POSTERIOR COMMUNICATING ARTERY (R PCA) AND RIGHT SUPERIOR CEREBELLAR ARTERY (R SCA) INFARCTION, WHICH WERE DIFFERENT VESSELS THAN THE ONE TREATED. IN THE PHYSICIAN¿S OPINION, THE INFARCTION WAS DUE TO FORMATION OF PLATELET CLOT IN THE COLLAPSED END OF THE SUBJECT STENT AND ITS MIGRATION INTO THE POSTERIOR CEREBRAL CIRCULATION VIA THE POS

  Patient problems: Ruptured Aneurysm; Stroke/CVA; Thromboembolism

  MAUDE report 11426290 ↗