Neuroform Atlas M003UZAS45210Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327382150), received between Jun 4, 2020 and Jun 18, 2025 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE SUBJECT STENT PREMATURELY DEPLOYED DURING THE PROCEDURE. 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 22288599 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST PROCEDURE, PATIENT EXPERIENCED WITH TIA (TRANSIENT ISCHEMIC ATTACK). THE PATIENT WAS ADMINISTERED WITH MEDICATION AND THE OUTCOME WAS RESOLVED, WITHOUT SEQUELAE. PATIENT WAS RETURNED TO BASELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 21962455 ↗
• InjuryJan 9, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM CASE, SUBJECT STENT WAS USED. SUBJECT STENT FAILED TO OPEN PROXIMALLY IN THE PATIENT¿S VESSEL THEREFORE ANOTHER STENT WAS TELESCOPED INSIDE THE FIRST SUBJECT STENT AS A MEDICAL INTERVENTION. 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 18473378 ↗
• MalfunctionJul 7, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN DEPLOYED THE SUBJECT STENT, IT DID NOT FULLY DETACH (PARTIALLY DEPLOYED DURING USE INSIDE THE PATIENT¿S ANATOMY). IT WAS REMOVED FULLY 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 17279697 ↗
• MalfunctionMay 11, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COILING OF THE ANEURYSM, THE SUBJECT STENT DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. 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 16909090 ↗
• MalfunctionDec 15, 2020Misassembled; Premature Activation; Misassembled; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE OF STENT ASSOCIATED COIL EMBOLIZATION, WHILE ADVANCING THE DELIVERY WIRE AND STENT INTO THE MICROCATHETER PRIOR TO POSITIONING OF THE STENT, WHEN THE FLUORO SAVER MARKER ON THE STENT DELIVERY WIRE MET THE RHV OF THE HUB OF MICROCATHETER AT THE PROXIMAL END, THE PHYSICIAN WAS NOT ABLE TO ALIGN THE STENT¿S DISTAL RADIOPAQUE MARKER AND THE DISTAL TIP MARKER OF THE STENT DELIVERY MICROCATHETER AS THE STENT WAS ALREADY COME OUT OF THE MICROCATHETER AT THE DISTAL END AND PREMATURELY DIPLOID MORE DISTALLY THAN THE PHYSICIAN WANTED IT TO BE POSITIONED. THE PROCEDURE WAS COMPLETED WITH THE AFOREMENTIONED STENT (STENT WHICH WAS PLACED MORE DISTALLY). NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009612 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT ADVANCED OVER THE WIRE AND THE STENT DISLODGE FROM THE DELIVERY SYSTEM MIDWAY IN THE MICROCATHETER BEFORE IT WAS PLACED IN THE TARGET SITE. THE DELIVERY SYSTEM HAD TO BE PULLED BACK OVER THE WIRE BY PULLING THE DISLODGED STENT ALONG UNTIL IT WAS REMOVED FROM THE MICROCATHETER. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S ANATOMY. THE SUBJECT STENT WAS ALSO REPORTED TO BE PREMATURELY DEPLOYED OUTSIDE THE PATIENT IN THE TUOHY BORST VALVE DURING REMOVAL FROM THE MICROCATHETER. NO PATIENT HARM WAS REPORTED DUE TO THIS EVENT. A MEDWATCH (MW5097311) WAS RECEIVED ON 03-NOVEMBER-2020 INDICATING THAT THE EVENT CAUSED UNKNOWN SERIOUS INJURY AND AS A RESULT UNKNOWN MEDICAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10926023 ↗
• MalfunctionSep 15, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT STENT WAS PREMATURELY DEPLOYED IN THE MICROCATHETER DURING POSITIONING. THE PHYSICIAN MANUALLY REMOVED THE SUBJECT STENT ALONG WITH MICROCATHETER FROM THE PATIENT. ANOTHER STENT WAS UTILIZED THAT PERFORMED PROPERLY AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10533555 ↗
• MalfunctionAug 4, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE PHYSICIAN WAS UNSHEATHING THE SUBJECT STENT THE PUSHER WIRE GOT KINKED. THE STENT WAS TAKEN OUT ALONG WITH THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE STENT DEPLOYED PREMATURELY DURING USE; THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED WITH AN AWARENESS DATE OF 20-JUL-2020. THE EVENT WILL BE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365583 ↗
• InjuryJul 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE, A STENT (SUBJECT DEVICE) WAS SUCCESSFULLY DEPLOYED AND VISUALIZED AT THE TARGET LOCATION. THE PHYSICIAN HAD DIFFICULTY REMOVING THE DELIVERY WIRE OF THE SUBJECT STENT. DURING THIS REMOVAL ATTEMPT, THE SUBJECT STENT PULLED BACK FROM ITS IMPLANTED POSITION AND STARTED POINTING INTO THE ANEURYSM. THE PHYSICIAN DEPLOYED ANOTHER STENT INTO A DIFFERENT LOCATION AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312803 ↗
• MalfunctionJun 4, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT HAD SLIPPED BACK AND LOST ACCESS WHILE WITHIN PATIENT ANATOMY. THE DISTAL END OF THE SUBJECT STENT DEPLOYED BUT NOT THE DESIRED LOCATION. 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; No Consequences Or Impact To Patient

  MAUDE report 10121649 ↗