Neuroform Atlas M003UZAS40300Recalls & reported problems
Stryker Corporation · WITHOUT TIP Stent System · Class 3 · 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 07613327382181), received between Jul 7, 2020 and Jul 7, 2020 — 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
- Infarction, Cerebral1
- Thrombosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 10242107 ↗InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING STENT-ASSISTED COILING PROCEDURE FOR AN ANEURYSM LOCATED AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), AT MAIN BRANCHING (TRIFURCATION) WITH THE SUBJECT STENT, THERE WAS STENT THROMBOSIS DUE TO PLATELET AGGREGATION TO THE OSTIUM OF THE STENTED BRANCH. RESOLVED AFTER INJECTION OF ABCIXIMAB MEDICATION. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENT OF STENT THROMBOSIS WAS ASSESSED AS SERIOUS ADVERSE EVENT AND RELATED TO THE SUBJECT STENT AND THE INDEX PROCEDURE. THE ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE.
Patient problems: Thrombosis
MAUDE report 10242106 ↗
Other Intracranial coil-assist stent devices
- Neuroform Atlas M003UZAS30240Stryker Corporation · Intracranial coil-assist stent13 reports
- Neuroform Atlas M003UZAS30210Stryker Corporation · Intracranial coil-assist stent12 reports
- Neuroform Atlas M003UZAS45210Stryker Corporation · Intracranial coil-assist stent11 reports
- Neuroform Atlas M003UZAS45300Stryker Corporation · Intracranial coil-assist stent10 reports
- Neuroform Atlas M003UZAS40210Stryker Corporation · Intracranial coil-assist stent9 reports
- Stent LEV3018-PMAMicrovention, Inc. · Intracranial coil-assist stent7 reports
- Neuroform Atlas M003UZAS30150Stryker Corporation · Intracranial coil-assist stent6 reports
- Neuroform Atlas M003UZAS40240Stryker Corporation · Intracranial coil-assist stent1 death6 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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