Neuroform Atlas M003STAS40210Recalls & reported problems
Stryker Corporation · WITH TIP Stent System · Class f · Implant
All models of Neuroform Atlas (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252656074), received between Jul 19, 2018 and Jul 19, 2018 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Transient Ischemic Attack2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 5 MONTH-POST SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE BASILAR APEX, THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA). TREATMENT WAS REQUIRED WITH HOSPITALIZATION/PROLONGED HOSPITALIZATION. THE ADVERSE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE TIA WAS RELATED TO THE ATLAS STENT (SUBJECT DEVICE). ACCORDING TO THE SITE, THE TIA WAS RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY/MEDICATION.
Patient problems: Transient Ischemic Attack
MAUDE report 7704615 ↗InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 5 MONTH-POST SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE BASILAR APEX, THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA). TREATMENT WAS REQUIRED WITH HOSPITALIZATION/PROLONGED HOSPITALIZATION. THE ADVERSE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE TIA WAS RELATED TO THE ATLAS STENT (SUBJECT DEVICE). ACCORDING TO THE SITE, THE TIA WAS RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY/MEDICATION.
Patient problems: Transient Ischemic Attack
MAUDE report 7704609 ↗
Other intracranial neurovascular stent devices
- CERENOVUS ENTERPRISE ENF402312Medos International Sàrl · intracranial neurovascular stent1 death90 reports
- PulseRider Aneurysm Neck Reconstruction Device 201-DMedos International Sàrl · Intracranial Neurovascular Stent2 deaths74 reports
- CERENOVUS ENTERPRISE ENF402300Medos International Sàrl · intracranial neurovascular stent2 deaths66 reports
- CERENOVUS ENTERPRISE ENF403012Medos International Sàrl · intracranial neurovascular stent1 death42 reports
- CERENOVUS ENTERPRISE ENF452212Medos International Sàrl · intracranial neurovascular stent41 reports
- CERENOVUS ENTERPRISE ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401600Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF452812Medos International Sàrl · intracranial neurovascular stent31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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