NEUROFORM EZ 3 M003N3EZ25150Recalls & 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 04546540697738), received between May 17, 2016 and May 17, 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
- Stroke/CVA1
- Thrombosis1
- Vasoconstriction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING ANGIOPLASTY, A STENT (SUBJECT DEVICE) WAS PLACED IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) FROM THE DISTAL M1 TO THE PROXIMAL M2 BRANCH TO PIN THE PLAQUE AGAINST THE WALLS OF THE ARTERY. FOLLOW UP ANGIOGRAPHY SHOWED WIDE PATENCY OF THE STENT AND THAT THE PLAQUE WAS SECURELY FASTENED AGAINST THE WALLS OF THE ARTERY. VERAPAMIL WAS ADMINISTERED INTRA-ARTERIALLY TO TREAT MILD VASOSPASM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). AN ADDITIONAL FOLLOW UP ANGIOGRAPHY SHOWED IMPROVEMENT OF THE VASOSPASM, WIDE PATENCY OF THE STENT WITH NO EVIDENCE OF IN-STENT THROMBOSIS AND NO EVIDENCE OF THROMBOEMBOLIC COMPLICATIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY; HOWEVER, APPROXIMATELY FIVE (5) DAYS LATER THE PATIENT RETURNED HAVING MILD WORD FINDING DIFFICULTIES. IMAGING SHOWED A PARTIAL OCCLUSION OF THE STENT FROM THE MID TO THE DISTAL PORTION OF THE DEVICE, RESULTING IN PARTIAL OCCLUSION OF THE M2 BRANCH; HOWEVER, WITH SUPPORTIVE FILLING FROM COLLATERAL CIRCULATION. MECHANICAL CLOT ASPIRATION AND BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE COMPLICATION, WHICH RESULTED IN SOME IMPROVEMENT OF FLOW BUT A PROMINENT OCCLUSION AT THE M2 LEVEL REMAINED. A THROMBO
Patient problems: Stroke/CVA; Thrombosis; Vasoconstriction
MAUDE report 5660056 ↗
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