MReye G42414Recalls & reported problems
Cook Incorporated · MReye Embolization Coil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002424142), received between Sep 15, 2020 and Sep 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN MREYE EMBOLIZATION COIL FOR A COIL EMBOLIZATION OF A COLLATERAL VESSEL OF THE PULMONARY ARTERY. AFTER PLACING THE COIL, THE OPERATOR NOTICED THE COIL WAS SEPARATED. ONE FRAGMENT WAS PLACED IN THE COLLATERAL VESSEL AND THE OTHER REMAINED INSIDE THE CATHETER. THE FRAGMENT IN THE COLLATERAL VESSELS "SEEMED TO EMBOLIZE THE COLLATERAL VESSELS" SO IT WAS DETERMINED THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10535431 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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