NEUROFORM EZ 3 M003N3EZ45300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540697882), received between Jun 10, 2019 and Oct 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6)2015, THE PATIENT WAS TREATED FOR A BASILAR ARTERY ANEURYSM WITH THE SUBJECT STENT. THE PATIENT SUFFERED A STROKE DURING THE PROCEDURE AND WAS ADMITTED INTO INTENSIVE CARE UNIT (ICU). POST PROCEDURAL IMAGING WAS NOT CLEAR DUE TO MUCH REFLECTION. PATIENT WAS THEN DISCHARGED BUT HAD DISABILITY AND SEVERE HEADACHE. PATIENT WAS RE-ADMITTED INTO THE ICU AND GIVEN INTRAVENOUS STEROIDS FOR BRAIN SWELLING. PATIENT REPORTED TO BE ON PAIN AND MIGRAINE MEDICATION FOR THE LAST 6 YEARS DUE TO PRESSURE INSIDE THE HEAD. POST-SURGICAL FOLLOW UPS HAVE BEEN UNSUCCESSFUL AS OTHER PHYSICIANS REPORT TO BE UNABLE TO FIND THE SOURCE OF THE PAIN. PATIENT IS NOT IN CONTACT WITH PHYSICIAN WHO PERFORMED PROCEDURE DUE TO CONFLICT. PATIENT IS CURRENTLY ON MIGRAINE TREATMENT, BLOOD THINNER AND ANTIHYPERTENSIVES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Cerebral Edema; Headache; Stroke/CVA

  MAUDE report 12617852 ↗
• MalfunctionJun 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONCE THE STENT WAS DEPLOYED, ONE OF THE DISTAL MARKERS LOOKED OUT OF ALIGNMENT. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8685459 ↗