MReye G42419Recalls & reported problems
Cook Incorporated · MReye Embolization Coil · Class 2 · Implant
All models of MReye (13)
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 00827002424197), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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
Device problems
- Difficult to Advance1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Embolism/Embolus1
- Reduced Blood Flow1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2023Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT A MREYE EMBOLIZATION COIL MIGRATED. THE DEVICE WAS REQUIRED FOR EMBOLIZATION OF A SEQUESTER ARTERY. DURING THE PROCEDURE, THE USER PLACED TWO UNKNOWN COILS. WHEN ATTEMPTING TO PLACE A THIRD, MREYE COIL, THE COIL WOULD NOT ADVANCE OUT OF THE CATHETER. UPON ATTEMPTED REMOVAL, THE MREYE COIL EMBOLIZED THE RIGHT ILIAC ARTERY. AS A RESULT, THE PATIENT EXPERIENCED "BORDERLINE COMPARTMENT SYNDROME" AND A "POSSIBLE TROPHIC PROBLEM". THE FOLLOWING DAY, AN ARTERIOTOMY SURGERY WAS REQUIRED TO REMOVE THE COIL FROM THE RIGHT ILIAC ARTERY. THE PATIENT ALSO REQUIRED AN EXTENDED STAY IN THE "ITE". NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus; Reduced Blood Flow
MAUDE report 16399533 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 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.
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