MReye G42454Recalls & reported problems
Cook Incorporated · MReye Embolization Coil · Class 2 · Implant
All models of MReye (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002424548), received between Jun 21, 2018 and Jun 21, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Stretched” (2 reports).
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
Device problems
- Stretched2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2018Stretched
THE COMPLAINANT REPORTED THAT THE MREYE EMBOLIZATION COIL COULD NOT EXIT FROM THE END OF THE CATHETER. THE CATHETER AND THE COIL WERE REMOVED FROM THE PATIENT'S BODY, AND OTHER COIL SIZES WERE USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED APPROXIMATELY 6CM (CENTIMETERS), MEASURING 4MM (MILLIMETERS) FROM THE DISTAL OR NON-WELDED END OF THE COIL. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7625242 ↗MalfunctionJun 21, 2018Stretched
THE COMPLAINANT REPORTED THAT THE MREYE EMBOLIZATION COIL COULD NOT EXIT FROM THE END OF THE CATHETER. THE CATHETER AND THE COIL WERE REMOVED FROM THE PATIENT'S BODY, AND OTHER COIL SIZES WERE USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7625144 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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