NEUROFORM EZ 3 M003N3EZ35200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540697806), received between Nov 30, 2016 and Dec 6, 2016 — classified as 2 deaths.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STENTING PROCEDURE WITH THE SUBJECT DEVICE AND A NON-STRYKER DEVICE, BOTH DEVICES THROMBOSED. ADMINISTRATION OF PHARMACOLOGICAL AGENTS TO CLEAR THE CLOTS WAS PERFORMED. THE PATIENT WAS PLACED IN PALLIATIVE CARE UNTIL DEATH OCCURED 3 DAYS POST-PROCEDURE. THE PHYSICIAN HAS ESTABLISHED THE RELATIONSHIP TO THE SUBJECT DEVICE AS SERIOUS, EXPECTED, RELATED.

  Patient problems: Death; Thrombosis

  MAUDE report 6147449 ↗
• DeathNov 30, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT HAD AN UN-RUPTURED, WIDE-NECK, BASILAR TIP ANEURYSM, AND THE PHYSICIAN WANTED TO PLACE TWO ANEURYSM BRIDGING STENTS IN A Y-STENTING CONFIGURATION IN ORDER TO PERFORM COILING EMBOLIZATION. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO TRACK A MICROCATHETER THROUGH THE LUMEN OF THE IMPLANTED STENT (SUBJECT DEVICE), THE STENT MARKER BANDS MOVED DISTALLY. IN SPITE OF THE STENT MOVEMENT, THE PATIENT REMAINED IN STABLE CONDITION. THE PHYSICIAN ATTEMPTED TO ADVANCE A COMPETITOR MICROCATHETER OVER THE GUIDEWIRE THROUGH THE LUMEN OF THE STENT ENCOUNTERING RESISTANCE. THE PHYSICIAN COULD NOT CONFIRM IF THE COMPETITOR MICROCATHETER HAD ADVANCED THROUGH THE LUMEN OF THE IMPLANTED STENT; THEREFORE, A DYNA CT WAS PERFORMED TO CONFIRM POSITION OF THE COMPETITOR MICROCATHETER. THE PHYSICIAN WAS UNSUCCESSFUL IN CONFIRMING POSITION OF THE COMPETITOR MICROCATHETER; THEREFORE, REMOVED THE MICROCATHETER AND PROCEEDED TO ADVANCE A COMPETITOR BALLOON CATHETER OVER THE GUIDEWIRE. IT WAS REPORTED THAT DURING THE PROCESS OF ADVANCEMENT OF THE BALLOON AND GUIDEWIRE, THE PATIENT BECAME VERY HYPERTENSIVE. CONTRAST WAS INJECTED REVEALING AN EXTRAVASATION COMING FROM THE BASILAR TIP ANEURYSM A

  Patient problems: Death; Hemorrhage, Subarachnoid

  MAUDE report 6135930 ↗