Neuroform Atlas M003STAS30150Recalls & 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 07613252656005), received between Dec 10, 2018 and Nov 29, 2021 — 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
- Ruptured Aneurysm1
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL TRIAL THE PATIENT SUFFERED A CEREBRAL ANEURYSM RUPTURE 10 MONTHS POST PROCEDURE WITH RELATION TO THE SUBJECT STENT PER CLINICAL ENDPOINT COMMITTEES (CEC). THE PATIENT WAS HOSPITALIZED AND GIVEN MEDICATION FOR TREATMENT. THE EVENT RESOLVED WITH NO EFFECTS TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Ruptured Aneurysm
MAUDE report 12886765 ↗InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT THE 12 MONTH-FOLLOW-UP A SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT LEFT OCCLUDED "CULPRIT" ARTERY (OCA) WAS NONDOMINANT AND APPEARS OCCLUDED INTRASTENT (100%). LARGE PATENT LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) SUPPLIES LEFT POSTERIOR CEREBRAL ARTERY (PCA) TERRITORY BASILAR ARTERY AND RIGHT PCA STENTS (SUBJECT DEVICE) ARE PATENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: Stenosis
MAUDE report 8148796 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page