MReye G42408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002424081), received between May 18, 2016 and Jun 20, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2018Stretched; Structural Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE EMBOLIZATION COIL HAD DEPLOYMENT ISSUES AND IT CURLED NEAR THE HUB-LUMEN CONNECTION. FURTHERMORE, IT WAS NOTED THAT THE COIL WAS STRETCHED AT THE NON-WELDED END. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7622323 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PDA CLOSURE, THE MREYE EMBOLIZATION COIL WAS DEPLOYED AND IT MIGRATED TO THE RIGHT PULMONARY ARTERY. THE COIL WAS RETRIEVED VIA SNARE BUT UPON REMOVAL IT MIGRATED AGAIN TO THE LEFT PULMONARY ARTERY. THE COIL WAS AGAIN SNARED AND RETRIEVED FROM THE PATIENT¿S BODY. AS REPORTED, THE DEVICE DID NOT MALFUNCTION AND THIS WAS A RARE PATIENT ANOMALY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7525359 ↗
• MalfunctionMay 18, 2016Material Separation; Material Separation

  AN EMBOLIZATION PROCEDURE WAS BEING PERFORMED ON THE MALE PATIENT. THE GUIDE CATHETER WAS PLACED AND THE COIL WAS PLACED THROUGH THE GLIDE CATHETER WHEN THE TIP OF THE COIL BROKE OFF, DURING DEPLOYMENT OF THE COIL. THE GLIDE CATHETER WAS ABOUT TO BE USED TO REMOVE THE TIP OF THE COIL FROM THE RIGHT ATRIUM. THE REMAINING COIL STAYED IN THE PATIENT AS INTENDED WITHOUT INCIDENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5664277 ↗