Neuroform Atlas M003UZAS30210Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327382211), received between Jul 7, 2020 and May 18, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Premature Activation

  IT WAS REPORTED THAT THE SUBJECT STENT WAS ATTEMPTED TO BE ADVANCED THROUGH THE MICROCATHETER. THE SUBJECT STENT MET RESISTANCE AND THE DELIVERY WIRE/STENT WOULD NOT ADVANCE. THE SUBJECT STENT WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT STENT DEPLOYED PREMATURELY 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 25202858 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT STENT STARTED TO GO INTO THE MICROCATHETER, IT MET RESISTANCE AND COULD NOT ADVANCE. WHEN ATTEMPTING TO PULL BACK ON THE SUBJECT STENT DELIVERY WIRE, IT BROKE. 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 24451314 ↗
• MalfunctionDec 12, 2024Entrapment of Device; Migration; Entrapment of Device; Migration

  IT WAS REPORTED THAT DURING STENT ASSISTED COILING ANEURYSM PROCEDURE, THE OPERATOR DEPLOYED SUCCESSFULLY THE SUBJECT STENT AT THE MIDDLE CEREBRAL ARTERY LOCATION. WHEN ATTEMPTING THE TRANSVERSE INTO THE PROXIMAL END OF THE SUBJECT STENT, RESISTANCE WAS FELT. WHEN THE OPERATOR PULLED THE MICROCATHETER BACK, THE SUBJECT STENT WAS DRAGGED OUT OF ITS INTENDED POSITION. THE OPERATOR THINKS THE SUBJECT STENT BECAME WEDGED INTO THE MICROCATHETER ALONG WITH THE DELIVERY WIRE. AFTER THE MICROCATHETER WAS REMOVED THE SUBJECT STENT WAS NOT FOUND, AND IS THOUGHT TO BE LEFT INSIDE THE PATIENT'S ANATOMY. THE PATIENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20918164 ↗
• MalfunctionNov 21, 2024Premature Activation; Premature Activation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE STENT SUBJECT DEVICE WAS PREMATURELY DEPLOYED INSIDE THE CATHETER 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 20753818 ↗
• MalfunctionJul 6, 2023Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM TREATMENT PROCEDURE, THE PHYSICIAN DELIVERED THE SUBJECT STENT THROUGH A MICROCATHETER. UPON DEPLOYMENT IT APPEARED THAT THE DISTAL END OF THE SUBJECT STENT DID NOT OPEN. THE PHYSICIAN CONTINUED TO DEPLOY THE SUBJECT STENT AND THE PROXIMAL END OPENED IN THE A1 SEGMENT. THE DISTAL END OF THE SUBJECT STENT DID NOT OPEN. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO WITHDRAW THE STENT DELIVERY WIRE (SDW) BUT THE SDW FELT STUCK IN THE DISTAL SEGMENT OF THE SUBJECT STENT. AFTER FURTHER ATTEMPTS TO PULL/ REMOVE THE SDW, IT WAS SUCCESSFULLY REMOVED. THE PHYSICIAN ADVANCED A GUIDEWIRE AND A MICROCATHETER TO THE DISTAL END OF THE SUBJECT STENT. WHEN THE MICROCATHETER REACHED THE DISTAL END OF THE SUBJECT STENT, THE DISTAL END SPRUNG OPEN AND FULLY APPOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT. THE PATIENT¿S CONDITION WAS STABLE AND WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265499 ↗
• InjuryJun 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER DEPLOYING THE SUBJECT STENT IN THE M2/M1 VESSEL THE OPERATOR TRIED TO RE-CROSS THE WIRE TO SELECT THE OTHER VESSEL FOR THE SECOND STENT. THE GUIDEWIRE GOT STUCK ON TO THE SUBJECT STENT. WHILE TRYING TO FREE THE WIRE, THE OPERATOR PULLED OUT A PORTION OF THE SUBJECT STENT. THE PATIENT¿S M1 VESSEL APPEARED TO BE OCCLUDED IN THE FINAL RUN. ADDITIONAL INFORMATION RECEIVED ON 23-JUNE-2023 CONFIRMED THAT A WIDE NECK ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION WAS BEING TREATED BUT THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN SECTION OF THE STENT WITH A SNARE BUT WAS UNSUCCESSFUL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 17104766 ↗
• MalfunctionMay 30, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM PROCEDURE, THE SUBJECT STENT WAS INSERTED INTO THE MICROCATHETER WITHOUT ANY ISSUE. WHILE ADVANCING THE SUBJECT STENT FURTHER INSIDE THE MICROCATHETER RESISTANCE WAS ENCOUNTERED AND IT COULD NO LONGER BE ADVANCED. THE SUBJECT STENT WAS REMOVED AND THE PHYSICIAN BELIEVES 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 17023235 ↗
• MalfunctionMar 13, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT (SUBJECT DEVICE) DEPLOYED 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 16527415 ↗
• MalfunctionNov 15, 2022Entrapment of Device; Migration; Entrapment of Device; Migration

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, WHEN THE PHYSICIAN TRIED TO RETRIEVE THE STENT DELIVERY WIRE AFTER DEPLOYMENT OF THE SUBJECT STENT, THE STENT DELIVERY WIRE CAUGHT ON THE SUBJECT STENT CREATING A FORCE THAT PULLED THE STENT PROXIMALLY. THE DELIVERY WIRE FELT STUCK AND UNABLE TO RETRIEVE INTO THE MICROCATHETER. THE DISTAL STENT TINES STAYED IN PLACE BUT THE PROXIMAL STENT TINES SEEMED TO MIGRATE PROXIMALLY A LITTLE DURING RETRIEVAL OF THE DELIVERY WIRE. THE PHYSICIAN WAS ULTIMATELY ABLE TO GET THE DELIVERY WIRE FREE. THIS CAUSED A SURGICAL DELAY OF 5 MIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT EITHER DUE TO THIS EVENT OR DUE TO THE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802210 ↗
• InjuryNov 8, 2022Entrapment of Device; Migration; Entrapment of Device; Migration

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, PHYSICIAN SUCCESSFULLY DEPLOYED THE SUBJECT STENT ACROSS THE NECK OF THE ANEURYSM WHICH HAD STENOSED VESSEL. HE ATTEMPTED TO ADVANCE THE MICROCATHETER OVER THE STENT DELIVERY WIRE (SDW) JUST PROXIMAL TO THE ANEURYSM, BUT WAS UNABLE TO DO SO. HE WAS ALSO UNABLE TO REMOVE THE SDW SO HAD TO USE SOME FORCE TO GET IT REMOVED. HOWEVER, IT WAS NOTICED IN IMAGING THAT THE SUBJECT STENT HAD SIGNIFICANTLY MOVED/STRETCHED. PHYSICIAN DID SEVERAL RUNS AND TWO 3D SPINS WHICH MADE THE SUBJECT STENT BOUNCE BACK TO ITS TARGET POSITION. THERE WAS A SURGICAL DELAY OF 40 MIN AND PATIENT WAS ADMINISTERED WITH INTEGRILIN. 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 15753011 ↗
• MalfunctionMar 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COILING PROCEDURE FOR ANEURYSM LOCATED IN THE ACOM, THE RADIOPAQUE MARKER OF THE SUBJECT STENT DELIVERY WIRE DETACHED AND FELL OFF IN THE MICRO CATHETER. PHYSICIAN DIDN'T FELT ANYTHING ABNORMAL DURING THE WITHDRAWAL OF THE DELIVERY WIRE BUT NOTICED IT WHILE TRACKING UP HIS FIRST COIL THROUGH THE MICRO CATHETER. SURGICAL DELAY OF MORE THAN 30 MINUTES WAS REPORTED DURING THE PROCEDURE. 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 11572157 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1-MONTH POST-PROCEDURE OF STENT-ASSISTED COILING WITH TWO SUBJECT STENTS, THE PATIENT EXPERIENCED ISCHEMIC STROKE WITH REGRESSIVE RIGHT PARESIS AND SLURRED SPEECH. KARDEGIC 75MG/DAY MEDICATION WAS STOPPED 15 DAYS BEFORE THE ADVERSE EVENT DATE. THIS ADVERSE EVENT OF ISCHEMIC STROKE WAS ASSESSED AS NON-SERIOUS AND WAS RESOLVED, WITHOUT SEQUELAE THE NEXT DAY.

  Patient problems: Infarction, Cerebral

  MAUDE report 10241786 ↗