Neuroform Atlas M003STAS30210Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252656012), received between Jun 29, 2021 and Jul 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT WAS INSERTED INTO THE MICROCATHETER AND SLIGHT RESISTANCE WAS ENCOUNTERED AT THE MICROCATHETER PROXIMAL SHAFT. WHILE PUSHING AND PULLING THE SUBJECT STENT DELIVERY WIRE BACK AND FORTH, IT BROKE OFF. THE SUBJECT STENT 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 19667172 ↗MalfunctionJun 29, 2021Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) WAS INSERTED INTO THE MICROCATHETER AND WAS PULLED TO ALIGN FOR DEPLOYMENT POSITION. DURING THIS ATTEMPT, THE SUBJECT STENT DETACHED PREMATURELY FROM THE DELIVERY WIRE INSIDE OF MICROCATHETER. THE DETACHED SUBJECT STENT WAS REMOVED ALONG WITH THE REMOVAL OF 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 12086658 ↗
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