MReye G20948Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002209480), received between May 11, 2018 and May 11, 2018 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Foreign Body Reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2017 A PATIENT THAT UNDERWENT GONADAL VEIN EMBOLISATION (LEFT SIDE VARICOCELE) WAS SUFFERING FROM LOCALIZED PAIN AT THE SURGICAL SITE. ON (B)(6) 2018, THE PATIENT REPORTED HE STILL HAD COMPLICATION/PAIN IN THE SURGICAL AREA. AT THIS TIME, THE PATIENT¿S MEDICAL TEAM DETERMINED HE DEVELOPED AN ALLERGIC REACTION TO THE IMPLANTED COILS/FIBERS. THE TEAM STATED THEY ARE PLANNING TO REMOVE THE COILS AND/OR HIS GONADAL VEIN WITH ASSOCIATED OR AFFECTED ORGANS. ON (B)(6) 2018, SPECIFIC DEVICES, LOTS AND QUANTITIES OF THE IMPLANTED COILS WERE REPORTED. AS REPORTED, A TOTAL OF 33 VARIOUS COOK INC. COILS AND AN UNSPECIFIED AMOUNT OF COMPETITOR COILS WERE IMPLANTED TWO MONTHS BEFORE (B)(6) 2017. THE FOLLOWING MEDWATCH REPORTS ARE FOR COILS IMPLANTED IN THIS SAID PATIENT. MEDWATCH 1820334-2018-01398 ¿ LOT 7423636 ¿ QUANTITY 5 DEVICES; MEDWATCH 1820334-2018-01399 ¿ LOT 7292138 ¿ QUANTITY 4 DEVICES; MEDWATCH 1820334-2018-01400 ¿ LOT 7815839 ¿ QUANTITY 3 DEVICES; MEDWATCH 1820334-2018-03888 ¿ LOT 7858778 ¿ QUANTITY 6 DEVICES; MEDWATCH 1820334-2018-01389 ¿ LOT 7698119 ¿ QUANTITY 7 DEVICES; MEDWATCH 1820334-2018-01390 ¿ LOT 7262416 ¿ QUANTITY 8 DEVICES.
Patient problems: Foreign Body Reaction
MAUDE report 7506596 ↗InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2017 A PATIENT THAT UNDERWENT GONADAL VEIN EMBOLISATION (LEFT SIDE VARICOCELE) WAS SUFFERING FROM LOCALIZED PAIN AT THE SURGICAL SITE. ON (B)(6) 2018, THE PATIENT REPORTED HE STILL HAD COMPLICATION/PAIN IN THE SURGICAL AREA. AT THIS TIME, THE PATIENT¿S MEDICAL TEAM DETERMINED HE DEVELOPED AN ALLERGIC REACTION TO THE IMPLANTED COILS/FIBERS. THE TEAM STATED THEY ARE PLANNING TO REMOVE THE COILS AND/OR HIS GONADAL VEIN WITH ASSOCIATED OR AFFECTED ORGANS. ON 04/24/2018, SPECIFIC DEVICES, LOTS AND QUANTITIES OF THE IMPLANTED COILS WERE REPORTED. AS REPORTED, A TOTAL OF 33 VARIOUS COOK INC. COILS AND AN UNSPECIFIED AMOUNT OF COMPETITOR COILS WERE IMPLANTED TWO MONTHS BEFORE (B)(6) 2017. THE FOLLOWING MEDWATCH REPORTS ARE FOR COILS IMPLANTED IN THIS SAID PATIENT. MEDWATCH 1820334-2018-01398 ¿ LOT 7423636 ¿ QUANTITY 5 DEVICES, MEDWATCH 1820334-2018-01399 ¿ LOT 7292138 ¿ QUANTITY 4 DEVICES, MEDWATCH 1820334-2018-01400 ¿ LOT 7815839 ¿ QUANTITY 3 DEVICES, MEDWATCH 1820334-2018-03888 ¿ LOT 7858778 ¿ QUANTITY 6 DEVICES, MEDWATCH 1820334-2018-01389 ¿ LOT 7698119 ¿ QUANTITY 7 DEVICES, MEDWATCH 1820334-2018-01390 ¿ LOT 7262416 ¿ QUANTITY 8 DEVICES.
Patient problems: Foreign Body Reaction
MAUDE report 7506407 ↗
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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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