NEUROFORM EZ 3 M003N3EZ25200Recalls & reported problems
Stryker Corporation · Stent System · Class f · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540697745), received between Aug 22, 2016 and Aug 22, 2016 — classified as 1 injury.
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 Problem1
Patient problems
- Infarction, Cerebral1
- Neurological Deficit/Dysfunction1
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT PRESENTED WITH A RIGHT M1 OCCLUSION. THE PATIENT UNDERWENT UNSUCCESSFUL THROMBECTOMY; THEREFORE, THE PHYSICIAN DEPLOYED A STENT (SUBJECT DEVICE) FROM THE POSTERIOR M2 DIVISION DOWN TO THE M1 SEGMENT. IT WAS REPORTED THAT ANGIOGRAPHY SHOWED IN-STENT THROMBOSIS AND 2 MG OF INTEGRILIN WERE THEN ADMINISTERED TO TREAT THE STENT THROMBOSIS. FOLLOW-UP ANGIOGRAPHY SHOWED THAT THE ANTERIOR M2 BRANCH REMAINED OCCLUDED. AFTER AN UNSUCCESSFUL ATTEMPT TO ACCESS THE OCCLUSION TO DEPLOY ANOTHER STENT, THE PHYSICIAN ADMINISTERED AN ADDITIONAL 5 MG OF INTEGRILIN TO THE RIGHT M1. FOLLOW-UP ANGIOGRAPHY DEMONSTRATED RECANALIZATION OF THE STENTED RIGHT M1 AND POSTERIOR M2 DIVISION WITH MINIMAL FLOW THROUGH THE ANTERIOR M2 BRANCH. A CT SCAN PERFORMED THE FOLLOWING DAY SHOWED EXTENSIVE INFARCTION OF THE ENTIRE RIGHT MCA TERRITORY AND MILD INCREASE IN MASS EFFECT. THE SWELLING CONTINUED TO INCREASE OVER TIME, AND OVERALL, THE MASS EFFECT INCREASED FROM 4 TO 8 MM TWO DAYS POST PROCEDURE. THIS WAS ASSOCIATED CLINICALLY WITH INCREASED SOMNOLENCE AND DIFFICULTIES MOVING EXTREMITIES. THE PHYSICIAN REPORTED THAT THE IN-STENT THROMBOSIS WAS RELATED TO THE PROCEDURE AND THE PATIENT'S CLINICAL SITUATIO
Patient problems: Infarction, Cerebral; Neurological Deficit/Dysfunction; Thrombosis
MAUDE report 5894263 ↗
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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